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Een werkzaamheids- en veiligheidsonderzoek van ALZ-801 bij APOE4/4 vroege AD-proefpersonen (APOLLOE4)

3 september 2026 bijgewerkt door: Alzheon Inc.

Een multicenter, gerandomiseerde, dubbelblinde, placebogecontroleerde fase 3-studie van de werkzaamheid, veiligheid en biomarkereffecten van ALZ-801 bij proefpersonen met vroege ziekte van Alzheimer en APOE4/4-genotype

This study is being conducted to evaluate the safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is a double-blind, randomized trial with one dose of ALZ-801 compared to placebo.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This is a multi-center, double-blind study that will evaluate 265 mg twice daily (BID) of ALZ-801, an oral tablet, over 78 weeks as a treatment for subjects (50-80 years old) with Early AD who are homozygous for the ε4 allele of the apolipoprotein gene (APOE4 homozygous or APOE4/4). The primary efficacy outcome assessment is a measure of cognition (ADAS-cog 13). Additional measures of global and functional impairments will also be assessed. Imaging and soluble biomarkers of AD and neurodegeneration will be measured and a sub-study to evaluate cerebrospinal fluid (CSF) biomarkers is also included.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

325

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1Z9
        • OCT Research ULC (dba Okanagan Clinical Trials)
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3S 1N2
        • Centricity Research
      • New Minas, Nova Scotia, Canada, B4N 3R7
        • Centricity Research
    • Ontario
      • Ottawa, Ontario, Canada, K1Z 1G3
        • Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic
      • Peterborough, Ontario, Canada, K9H 2P4
        • Kawartha Centre - Redefining Healthy Aging
      • Toronto, Ontario, Canada, M3B 2S7
        • Toronto Memory Program
    • Quebec
      • Gatineau, Quebec, Canada, J8T 8J1
        • Recherches Neuro-Hippocampe Inc. d/b/a Clinique de la Mémoire de l'Outaouais
  • Duitsland
      • Aachen, Duitsland, 52074
        • University Hospital RWTH Aachen Neurological Study Center
      • München, Duitsland, 80336
        • Klinikum der Universitaet Muenchen Innenstadt
      • Tübingen, Duitsland, 72076
        • Universitätsklinik fuer Psychiatrie und Psychotherapie
      • Westerstede, Duitsland, 26655
        • Studienzentrum Nord-West
  • Frankrijk
      • Marseille, Frankrijk, 13385
        • Centre Hospitalier Universitaire de Marseille - Hôpital de la Timone
      • Montpellier, Frankrijk, 43431
        • Hopital Gui de Chauliac - CHRU de Montpellier
      • Paris, Frankrijk, 75475
        • Hopital Lariboisiere - Fernand-Widal - AP-HP
      • Rouen, Frankrijk, 76031
        • Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen
      • Strasbourg, Frankrijk, 67200
        • Hopitaux Universitaires de Strasbourg Centre d'Investigation Clinique
      • Toulouse, Frankrijk, 31059
        • Centre de Recherche Clinique du Gerontopole - CHU Toulouse
      • Villeurbanne, Frankrijk, 69100
        • Centre de Recherche-Hopital Geriatrique de Charpennes
  • IJsland
      • Reykjavik, IJsland, 101
        • Memory Clinic, Landspitali University Hospital
  • Nederland
      • 's-Hertogenbosch, Nederland, 5223 LA
        • Brain Research Center Den Bosch
      • Amsterdam, Nederland, 1081 GN
        • Brain Research Center Amsterdam
      • Zwolle, Nederland, 8025 AZ
        • Brain Research Center Zwolle
  • Spanje
      • Barcelona, Spanje, 08028
        • Fundacia ACE - Institut Catala de Neurociencies Aplicadas
      • Madrid, Spanje, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spanje, 28027
        • Clinica Universidad de Navarra
      • Pamplona, Spanje, 31008
        • Clinica Universidad de Navarra
      • Terrassa, Spanje, 08221
        • Hospital Universitari MutuaTerrassa
      • Valencia, Spanje, 46017
        • Centro Hospital Universitario Dr. Preset
  • Tsjechië
      • Brno, Tsjechië, 656 91
        • Fakultní nemocnice u sv. Anny v Brně (St. Anne's University Hospital)
      • Brno, Tsjechië, 602 00
        • Medica 111, Spol. s r.o. - Neurologicka a Rehabilitacni Ambulance Brno, Centralni Pracoviste v Brne
      • Prague, Tsjechië, 160 00
        • Neuropsychiatrie s.r.o.
      • Rychnov nad Kněžnou, Tsjechië, 51601
        • Vestra Clinics - Dedicated Research Clinics
  • Verenigd Koninkrijk
      • Bristol, Verenigd Koninkrijk, BS32 4SY
        • Re:Cognition Health Ltd Bristol
      • London, Verenigd Koninkrijk, EC2Y 8EA
        • St. Pancras Clinical Research
      • Winchester, Verenigd Koninkrijk, SO21 1HU
        • Re-Cognition Health Ltd Winchester
    • Devon
      • Plymouth, Devon, Verenigd Koninkrijk, PL6 8BT
        • Re-Cognition Health Ltd Plymouth
    • Greater London
      • London, Greater London, Verenigd Koninkrijk, W1G 9JF
        • Re-Cognition Health Ltd London
    • North Lanarkshire
      • Motherwell, North Lanarkshire, Verenigd Koninkrijk, ML1 4UF
        • NeuroClin Glasgow Ltd
    • Surrey
      • Guildford, Surrey, Verenigd Koninkrijk, GU2 7YD
        • Re-Cognition Health Ltd Guildford
    • West Midlands
      • Birmingham, West Midlands, Verenigd Koninkrijk, B16 8LT
        • Re-Cognition Health Ltd Birmingham
  • Verenigde Staten
    • Arizona
      • Phoenix, Arizona, Verenigde Staten, 85004
        • Xenoscience
      • Scottsdale, Arizona, Verenigde Staten, 85297
        • CCT Research
      • Sun City, Arizona, Verenigde Staten, 85351
        • Banner Sun Health Research Institute
    • California
      • Costa Mesa, California, Verenigde Staten, 92626
        • ATP Clinical Research
      • Irvine, California, Verenigde Staten, 92780
        • Tilda Research
      • La Jolla, California, Verenigde Staten, 92037
        • UCSD Shiley-Marcos Alzheimer's Disease Research Center
      • Lomita, California, Verenigde Staten, 90717
        • Torrance Clinical Research Institute
      • Long Beach, California, Verenigde Staten, 90806
        • Collaborative NeuroScience Network LLC
      • Palo Alto, California, Verenigde Staten, 94304
        • Stanford University
      • Pasadena, California, Verenigde Staten, 91105
        • SC3 Research Group
      • Sacramento, California, Verenigde Staten, 95816
        • Sutter Health
    • Florida
      • Atlantis, Florida, Verenigde Staten, 33462
        • JEM Research Institute, Headlands Site
      • Bradenton, Florida, Verenigde Staten, 34205
        • Bradenton Research Center
      • Hialeah, Florida, Verenigde Staten, 33016
        • Galiz Research
      • Jupiter, Florida, Verenigde Staten, 33458
        • Alphab Global Research
      • Lady Lake, Florida, Verenigde Staten, 32159
        • Charter Research
      • Maitland, Florida, Verenigde Staten, 32751
        • K2 Medical Research, LLC
      • Miami, Florida, Verenigde Staten, 33137
        • Miami Jewish Health
      • Miami, Florida, Verenigde Staten, 33144
        • Y & L Advance Health Care, Inc /DBA Elite Clinical Research
      • Miami Beach, Florida, Verenigde Staten, 33140
        • Mount Sinai Medical Center
      • Naples, Florida, Verenigde Staten, 34105
        • Aqualane Clinical Research
      • Orlando, Florida, Verenigde Staten, 32819
        • Headlands Research Orlando
      • Orlando, Florida, Verenigde Staten, 32803
        • Charter Research
      • Palm Beach Gardens, Florida, Verenigde Staten, 33410
        • Advanced Research Consultants
      • Pompano Beach, Florida, Verenigde Staten, 33064
        • Quantum CNS Clinical Research
      • Port Orange, Florida, Verenigde Staten, 32127
        • Progressive Medical Research
      • Stuart, Florida, Verenigde Staten, 34997
        • ALZ Research and Treatment Center (A.R.T.C.)
      • Wellington, Florida, Verenigde Staten, 33414
        • ALZ Research and Treatment Center (A.R.T.C.)
      • West Palm Beach, Florida, Verenigde Staten, 33407
        • Premiere Research Institute
    • Georgia
      • Columbus, Georgia, Verenigde Staten, 31909
        • Columbus Memory Center
      • Decatur, Georgia, Verenigde Staten, 30030
        • Sandhill Research, LLC
    • Indiana
      • Fort Wayne, Indiana, Verenigde Staten, 46804
        • Fort Wayne Neurological Center
    • Louisiana
      • Shreveport, Louisiana, Verenigde Staten, 71103
        • Louisiana State University Health Sciences Center (LSUHSC)
    • Massachusetts
      • Plymouth, Massachusetts, Verenigde Staten, 02360
        • Headlands Research Eastern MA
    • Nevada
      • Las Vegas, Nevada, Verenigde Staten, 89106
        • WR-CRCN
    • New Jersey
      • Toms River, New Jersey, Verenigde Staten, 08755
        • Advanced Memory Research Center
    • New York
      • Albany, New York, Verenigde Staten, 12208
        • Neurological Associates of Albany
      • New York, New York, Verenigde Staten, 10016
        • NYU Alzheimer's Disease Research Center
      • Orangeburg, New York, Verenigde Staten, 10962
        • Kline Institute for Psychiatric Research
      • Rochester, New York, Verenigde Staten, 14620
        • University of Rochester Medical Center
      • Staten Island, New York, Verenigde Staten, 10312
        • Richmond Behavioral Associates
    • North Carolina
      • Greensboro, North Carolina, Verenigde Staten, 27410
        • Triad Clinical Trials
      • Matthews, North Carolina, Verenigde Staten, 28105
        • AMC Research
    • Ohio
      • Canton, Ohio, Verenigde Staten, 44718
        • NeuroScience Research Center
      • Dayton, Ohio, Verenigde Staten, 45459
        • Neurology Diagnostics, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten, 73106
        • IPS Research
    • Oregon
      • Portland, Oregon, Verenigde Staten, 97225
        • Center for Cognitive Health
    • Pennsylvania
      • Abington, Pennsylvania, Verenigde Staten, 19001
        • Abington Neurological Associates
      • Allentown, Pennsylvania, Verenigde Staten, 18104
        • Lehigh Center for Clinical Research
    • Rhode Island
      • East Providence, Rhode Island, Verenigde Staten, 02914
        • Rhode Island Mood & Memory Research Institute
    • Tennessee
      • Nashville, Tennessee, Verenigde Staten, 37212
        • Vanderbilt Center for Cognitive Medicine
    • Texas
      • Houston, Texas, Verenigde Staten, 77054
        • UT Health Science Center at Houston
    • Virginia
      • Fairfax, Virginia, Verenigde Staten, 22031
        • Re:Cognition Health
    • Washington
      • Bellevue, Washington, Verenigde Staten, 98007
        • Northwest Clinical Research Center
    • Wisconsin
      • Milwaukee, Wisconsin, Verenigde Staten, 53226
        • Medical College of Wisconsin

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

50 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Clinical diagnosis of MCI or Mild Dementia due to AD consistent with the National Institute on Aging-Alzheimer's Association (NIA-AA) Working Group Criteria.
  • Homozygous for the ε4 allele of the apolipoprotein E gene (APOE4/4).
  • MMSE score at Screening of 22 to 30 (inclusive).
  • CDR - Global score of 0.5 or 1 and CDR Memory Box Score of ≥ 0.5.
  • RBANS delayed memory index score ≤ 85.
  • Evidence of progressive memory loss over the last 12 months per investigator assessment

Exclusion Criteria:

  • Brain magnetic resonance imaging (MRI) indicative of significant abnormality per central reader, other than AD related atrophy. Computed tomography (CT) scan acceptable for subjects who cannot undergo MRI.
  • Diagnosis of neurodegenerative disorder other than AD.
  • Diagnosis of major depressive disorder (MDD) within one year prior to screening.
  • Currently taking memantine or has taken memantine within 12 weeks prior to the Baseline Visit.
  • History of suicidal behavior within one year prior to screening or has ongoing suicidal ideation.
  • History of seizures, excluding febrile seizures of childhood or a single distant seizure (> 5 years).
  • Medically confirmed history of recent cerebral infarct or transient ischemic attack within one year prior to screening.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: ALZ-801

ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one tablet of ALZ-801 265 mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265 mg tablet twice daily (BID).
Geneesmiddel: Experimental: ALZ-801

ALZ-801 tablet 265 mg once daily in the evening for the first 2 weeks, then ALZ-801 tablet 265 mg BID

Andere namen:
  • valiltramiprosaat
  • tramiprosaat prodrug
Geneesmiddel: Placebo Comparator: Placebo

Placebo tablet BID
Placebo-vergelijker: Placebo

Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study
Geneesmiddel: Placebo Comparator: Placebo

Placebo tablet BID

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Primary Cognitive Efficacy Endpoint (ADAS-Cog13)
Tijdsspanne: Baseline to Week 78

Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog13) scores.

The ADAS-Cog13 is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS-Cog13 consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity.
Baseline to Week 78
Incidence, Nature, and Severity of Treatment Emergent Adverse Events (TEAE)
Tijdsspanne: Entire study: approximately 82 weeks. (first dose of study drug until end of Safety Follow-up Visit at 28 +/- 7 days after the last dose (ie, 78-week treatment period plus 4-weeks follow-up after last dose up to total of 82 weeks)

Safety and tolerability as measured by incidence, nature and severity of treatment emergent adverse events (TEAE), serious TEAEs, and TEAEs leading to withdrawal.
Entire study: approximately 82 weeks. (first dose of study drug until end of Safety Follow-up Visit at 28 +/- 7 days after the last dose (ie, 78-week treatment period plus 4-weeks follow-up after last dose up to total of 82 weeks)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Key Secondary Endpoint (A-IADL-W)
Tijdsspanne: Baseline to Week 78

Change from baseline in Amsterdam - Instrumental Activities of Daily Living scores calculated using the weighted average method (A-IADL-W score). The A-IADL Questionnaire is a 70-item informant-based computerized questionnaire aimed at detecting deficits in complex functions at the early stages of AD. Instrumental ADL can be described as the activities necessary to function independently in society. These activities include, but are not limited to, cooking, doing finances, and shopping. They are complex everyday tasks, determined by multiple cognitive processes and controlled processing. They can be distinguished from basic ADL, which include basic self-care skills. The A-IADL-W has a score range of 0-100 and is calculated as follows: (sum of all scores / number of questions scored) × 25. For A-IADL-W, higher scores indicates worse functioning or more impairment.
Baseline to Week 78
Key Secondary Endpoint (CDR-SB)
Tijdsspanne: Baseline to Week 78

Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) scores. CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.
Baseline to Week 78
Functional Assessment (DAD)
Tijdsspanne: Baseline to Week 78

Change from baseline in Disability Assessment for Dementia (DAD)scores. The DAD consists of 40 items with a score range of 0-100 to evaluate the basic and instrumental activities of daily living of subjects with dementia. It is administered through an interview with the caregiver. Higher DAD scores indicate less disability or better function.
Baseline to Week 78
Global Cognition Assessment (MMSE)
Tijdsspanne: Baseline to Week 78

Change from baseline in Mini-Mental State Examination (MMSE) score. The MMSE is a measure of global cognition that is widely used for clinical staging of Alzheimer's Disease. It consists of 11 domains items for a score range of 0-30 to assess general cognitive function. Higher score on MMSE means better cognitive skills.
Baseline to Week 78

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Imaging Biomarker Endpoint (Hippocampal Volume)
Tijdsspanne: Baseline to Week 78

Change from baseline in total (bilateral) hippocampal volume (HV) (uL) as measured by Magnetic Resonance Imaging (MRI). HV atrophy is an early event in AD patients, especially in APOE4/4 homozygotes who show accelerated atrophy compared to APOE3/3 patients with Early AD. HV may be a marker of synaptic loss and neurodegeneration.
Baseline to Week 78
Imaging Biomarker Endpoint (Cortical Thickness [Whole Cortex])
Tijdsspanne: Baseline to Week 78

Change from baseline in total (bilateral) cortical thickness (mm) as measured by MRI. Brain MRI studies in Alzheimer's Disease patients show progressive cortical atrophy, reflecting progressive neurodegeneration.
Baseline to Week 78
Imaging Biomarker Endpoint (Cortical Thickness [Mayo Index])
Tijdsspanne: Baseline to Week 78

Change from baseline in total (bilateral) cortical thickness (mm) as measured by MRI. Brain MRI studies in Alzheimer's Disease patients show progressive cortical atrophy, reflecting progressive neurodegeneration. The Mayo Index refers specifically to the measurement of cortical thickness in the medial temporal lobe.
Baseline to Week 78
Imaging Biomarker Endpoint (Whole Brain Volume)
Tijdsspanne: Baseline to Week 78

Change from baseline in whole brain volume (uL) as measured by Magnetic Resonance Imaging (MRI).
Baseline to Week 78
Imaging Biomarker Endpoint (Ventricular Volume)
Tijdsspanne: Baseline to Week 78

Change from baseline in total (bilateral) ventricular volume (uL) as measured by Magnetic Resonance Imaging (MRI).
Baseline to Week 78
Imaging Biomarker Endpoint - DTI in Grey Matter Mean Diffusivity - Bilateral Caudate
Tijdsspanne: Baseline to Week 78

Change from baseline in Grey Matter Mean Diffusivity (Bilateral Caudate) as measured by Diffusion Tensor Imaging - Magnetic Resonance Imaging (DTI-MRI). The mean diffusivity (MD) is the average of the three main diffusion values (eigenvalues) obtained from the diffusion tensor imaging (DTI). It is expressed as mm2/s. This unit quantifies the average rate of water diffusion across all directions within a tissue, providing an overall measure of tissue microstructural properties. Lower MD value suggests better maintenance of microstructural integrity of a given brain tissue. Positive treatment effects of ALZ-801 on DTI would present as lower mean diffusivity compared with the placebo group.
Baseline to Week 78
Imaging Biomarker Endpoint - DTI in White Matter Mean Diffusivity (Bilateral Fornix)
Tijdsspanne: Baseline to Week 78

Change from baseline in Bilateral Fornix White Matter Mean Diffusivity as measured by Diffusion Tensor Imaging - Magnetic Resonance Imaging (DTI-MRI). The mean diffusivity (MD) is the average of the three main diffusion values (eigenvalues) obtained from the diffusion tensor imaging (DTI). It is expressed as mm2/s. This unit quantifies the average rate of water diffusion across all directions within a tissue, providing an overall measure of tissue microstructural properties. Lower MD value suggests better maintenance of microstructural integrity of a given brain tissue. Positive treatment effects of ALZ-801 on DTI would present as lower mean diffusivity compared with the placebo group.
Baseline to Week 78
Imaging Biomarker Endpoint - White Matter Fractional Anisotropy (Bilateral Fornix)
Tijdsspanne: Baseline to Week 78

Change from baseline in Bilateral Fornix White Matter Fractional Anisotropy as measured by Diffusion Tensor Imaging - Magnetic Resonance Imaging (DTI-MRI). Fractional anisotropy (FA) is a unitless, scalar value that measures the degree of anisotropic (directional) water diffusion within a voxel, ranging from 0 to 1. A value of 0 indicates perfectly isotropic (equal in all directions) diffusion, while a value of 1 indicates perfectly anisotropic (directional) diffusion. Higher FA value suggests better maintenance of microstructural integrity of a given brain tissue. Positive treatment effects of ALZ-801 on DTI would present as higher FA in the ALZ-801 group compared with the placebo group.
Baseline to Week 78
Cognitive Efficacy Endpoint (ADAS-Cog 13) - MCI Subgroup
Tijdsspanne: Baseline to Week 78

Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-cog 13) scores at 78 weeks.

The ADAS-Cog13 is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS-Cog13 consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity.
Baseline to Week 78
Cognitive Efficacy Endpoint (ADAS-Cog 13) - Mild Alzheimer's Disease(Mild AD) Subgroup
Tijdsspanne: Baseline to Week 78

Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-cog 13) scores at 78 weeks.

The ADAS-Cog13 is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS-Cog13 consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity.
Baseline to Week 78
A-IADL-W - MCI Subgroup
Tijdsspanne: Baseline to Week 78

Change from baseline in Amsterdam - Instrumental Activities of Daily Living scores calculated using the weighted average method (A-IADL-W score). The A-IADL Questionnaire is a 70-item informant-based computerized questionnaire aimed at detecting deficits in complex functions at the early stages of AD. Instrumental ADL can be described as the activities necessary to function independently in society. These activities include, but are not limited to, cooking, doing finances, and shopping. They are complex everyday tasks, determined by multiple cognitive processes and controlled processing. They can be distinguished from basic ADL, which include basic self-care skills. The A-IADL-W has a score range of 0-100 and is calculated as follows: (sum of all scores / number of questions scored) × 25. For A-IADL-W, higher scores indicates worse functioning or more impairment.
Baseline to Week 78
A-IADL-W - Mild AD Subgroup
Tijdsspanne: Baseline to Week 78

Change from baseline in Amsterdam - Instrumental Activities of Daily Living scores calculated using the weighted average method (A-IADL-W score). The A-IADL Questionnaire is a 70-item informant-based computerized questionnaire aimed at detecting deficits in complex functions at the early stages of AD. Instrumental ADL can be described as the activities necessary to function independently in society. These activities include, but are not limited to, cooking, doing finances, and shopping. They are complex everyday tasks, determined by multiple cognitive processes and controlled processing. They can be distinguished from basic ADL, which include basic self-care skills. The A-IADL-W has a score range of 0-100 and is calculated as follows: (sum of all scores / number of questions scored) × 25. For A-IADL-W, higher scores indicates worse functioning or more impairment.
Baseline to Week 78
CDR-SB - MCI Subgroup
Tijdsspanne: Baseline to Week 78

Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) scores. CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.
Baseline to Week 78
CDR-SB - Mild AD Subgroup
Tijdsspanne: Baseline to Week 78

Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) scores. CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.
Baseline to Week 78
Functional Assessment (DAD) - MCI Subgroup
Tijdsspanne: Baseline to Week 78

Change from baseline in Disability Assessment for Dementia (DAD)scores. The DAD consists of 40 items with a score range of 0-100 to evaluate the basic and instrumental activities of daily living of subjects with dementia. It is administered through an interview with the caregiver. Higher DAD scores indicate less disability or better function.
Baseline to Week 78
Functional Assessment (DAD) - Mild AD Subgroup
Tijdsspanne: Baseline to Week 78

Change from baseline in Disability Assessment for Dementia (DAD)scores. The DAD consists of 40 items with a score range of 0-100 to evaluate the basic and instrumental activities of daily living of subjects with dementia. It is administered through an interview with the caregiver. Higher DAD scores indicate less disability or better function.
Baseline to Week 78
Global Cognition Assessment (MMSE) - MCI Subgroup
Tijdsspanne: Baseline to Week 78

Change from baseline in Mini-Mental State Examination (MMSE) score. The MMSE is a measure of global cognition that is widely used for clinical staging of Alzheimer's Disease. It consists of 11 domains items for a score range of 0-30 to assess general cognitive function. Higher score on MMSE means better cognitive skills.
Baseline to Week 78
Global Cognition Assessment (MMSE) - Mild AD Subgroup
Tijdsspanne: Baseline to Week 78

Change from baseline in Mini-Mental State Examination (MMSE) score. The MMSE is a measure of global cognition that is widely used for clinical staging of Alzheimer's Disease. It consists of 11 domains items for a score range of 0-30 to assess general cognitive function. Higher score on MMSE means better cognitive skills.
Baseline to Week 78
Hippocampal Volume (MCI Subgroup)
Tijdsspanne: Baseline to Week 78

Change from baseline in total (bilateral) hippocampal volume (HV) (uL) as measured by Magnetic Resonance Imaging (MRI). HV atrophy is an early event in AD patients, especially in APOE4/4 homozygotes who show accelerated atrophy compared to APOE3/3 patients with Early AD. HV may be a marker of synaptic loss and neurodegeneration.
Baseline to Week 78
Hippocampal Volume (Mild AD Subgroup)
Tijdsspanne: Baseline to Week 78

Change from baseline in total (bilateral) hippocampal volume (HV) (uL) as measured by Magnetic Resonance Imaging (MRI). HV atrophy is an early event in AD patients, especially in APOE4/4 homozygotes who show accelerated atrophy compared to APOE3/3 patients with Early AD. HV may be a marker of synaptic loss and neurodegeneration.
Baseline to Week 78
Cortical Thickness (Whole Cortex) (MCI Subgroup)
Tijdsspanne: Baseline to Week 78

Change from baseline in total (bilateral) cortical thickness (mm) as measured by MRI. Brain MRI studies in Alzheimer's Disease patients show progressive cortical atrophy, reflecting progressive neurodegeneration.
Baseline to Week 78
Cortical Thickness (Whole Cortex) (Mild AD Subgroup)
Tijdsspanne: Baseline to Week 78

Change from baseline in total (bilateral) cortical thickness (mm) as measured by MRI. Brain MRI studies in Alzheimer's Disease patients show progressive cortical atrophy, reflecting progressive neurodegeneration.
Baseline to Week 78
Cortical Thickness (Mayo Index) (MCI Subgroup)
Tijdsspanne: Baseline to Week 78

Change from baseline in total (bilateral) cortical thickness (mm) as measured by MRI. Brain MRI studies in Alzheimer's Disease patients show progressive cortical atrophy, reflecting progressive neurodegeneration. The Mayo Index refers specifically to the measurement of cortical thickness in the medial temporal lobe versus the whole cortex.
Baseline to Week 78
Cortical Thickness (Mayo Index) (Mild AD Subgroup)
Tijdsspanne: Baseline to Week 78

Change from baseline in total (bilateral) cortical thickness (mm) as measured by MRI. Brain MRI studies in Alzheimer's Disease patients show progressive cortical atrophy, reflecting progressive neurodegeneration. The Mayo Index refers specifically to the measurement of cortical thickness in the medial temporal lobe versus the whole cortex.
Baseline to Week 78
Whole Brain Volume (MCI Subgroup)
Tijdsspanne: Baseline to Week 78

Change from baseline in whole brain volume (uL) as measured by Magnetic Resonance Imaging (MRI).
Baseline to Week 78
Whole Brain Volume (Mild AD Subgroup)
Tijdsspanne: Baseline to Week 78

Change from baseline in whole brain volume (uL) as measured by Magnetic Resonance Imaging (MRI).
Baseline to Week 78
Ventricular Volume (MCI Subgroup)
Tijdsspanne: Baseline to Week 78

Change from baseline in total (bilateral) ventricular volume (uL) as measured by Magnetic Resonance Imaging (MRI).
Baseline to Week 78
Ventricular Volume (Mild AD Subgroup)
Tijdsspanne: Baseline to Week 78

Change from baseline in total (bilateral) ventricular volume (uL) as measured by Magnetic Resonance Imaging (MRI).
Baseline to Week 78
Cognitive Efficacy Endpoint (ADAS-Cog 13) - Female Subgroup of the FAS
Tijdsspanne: Baseline to Week 78

Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-cog 13) scores at 78 weeks.

The ADAS-Cog13 is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS-Cog13 consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity.
Baseline to Week 78
Cognitive Efficacy Endpoint (ADAS-Cog 13) - Male Subgroup of the FAS
Tijdsspanne: Baseline to Week 78

Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-cog 13) scores at 78 weeks.

The ADAS-Cog13 is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS-Cog13 consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity.
Baseline to Week 78
A-IADL-W - Female Subgroup
Tijdsspanne: Baseline to Week 78

Change from baseline in Amsterdam - Instrumental Activities of Daily Living scores calculated using the weighted average method (A-IADL-W score). The A-IADL Questionnaire is a 70-item informant-based computerized questionnaire aimed at detecting deficits in complex functions at the early stages of AD. Instrumental ADL can be described as the activities necessary to function independently in society. These activities include, but are not limited to, cooking, doing finances, and shopping. They are complex everyday tasks, determined by multiple cognitive processes and controlled processing. They can be distinguished from basic ADL, which include basic self-care skills. The A-IADL-W has a score range of 0-100 and is calculated as follows: (sum of all scores / number of questions scored) × 25. For A-IADL-W, higher scores indicates worse functioning or more impairment.
Baseline to Week 78
A-IADL-W - Male Subgroup
Tijdsspanne: Baseline to Week 78

Change from baseline in Amsterdam - Instrumental Activities of Daily Living scores calculated using the weighted average method (A-IADL-W score). The A-IADL Questionnaire is a 70-item informant-based computerized questionnaire aimed at detecting deficits in complex functions at the early stages of AD. Instrumental ADL can be described as the activities necessary to function independently in society. These activities include, but are not limited to, cooking, doing finances, and shopping. They are complex everyday tasks, determined by multiple cognitive processes and controlled processing. They can be distinguished from basic ADL, which include basic self-care skills. The A-IADL-W has a score range of 0-100 and is calculated as follows: (sum of all scores / number of questions scored) × 25. For A-IADL-W, higher scores indicates worse functioning or more impairment.
Baseline to Week 78
CDR-SB - Female Subgroup
Tijdsspanne: Baseline to Week 78

Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) scores. CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.
Baseline to Week 78
CDR-SB - Male Subgroup
Tijdsspanne: Baseline to Week 78

Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) scores. CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.
Baseline to Week 78
Functional Assessment (DAD) - Female Subgroup
Tijdsspanne: Baseline to Week 78

Change from baseline in Disability Assessment for Dementia (DAD)scores. The DAD consists of 40 items with a score range of 0-100 to evaluate the basic and instrumental activities of daily living of subjects with dementia. It is administered through an interview with the caregiver. Higher DAD scores indicate less disability or better function.
Baseline to Week 78
Functional Assessment (DAD) - Male Subgroup
Tijdsspanne: Baseline to Week 78

Change from baseline in Disability Assessment for Dementia (DAD)scores. The DAD consists of 40 items with a score range of 0-100 to evaluate the basic and instrumental activities of daily living of subjects with dementia. It is administered through an interview with the caregiver. Higher DAD scores indicate less disability or better function.
Baseline to Week 78
Treatment Emergent Adverse Events (TEAE) - Females
Tijdsspanne: Entire study: approximately 82 weeks. (first dose of study drug until end of Safety Follow-up Visit at 28 +/- 7 days after the last dose (ie, 78-week treatment period plus 4-weeks follow-up after last dose up to total of 82 weeks)

Safety and tolerability as measured by incidence of treatment emergent adverse events (TEAE), serious TEAEs, and TEAEs experienced by at least 5% of participants in either treatment group
Entire study: approximately 82 weeks. (first dose of study drug until end of Safety Follow-up Visit at 28 +/- 7 days after the last dose (ie, 78-week treatment period plus 4-weeks follow-up after last dose up to total of 82 weeks)
Treatment Emergent Adverse Events (TEAE) - Males
Tijdsspanne: Entire study: approximately 82 weeks. (first dose of study drug until end of Safety Follow-up Visit at 28 +/- 7 days after the last dose (ie, 78-week treatment period plus 4-weeks follow-up after last dose up to total of 82 weeks)

Safety and tolerability as measured by incidence of treatment emergent adverse events (TEAE), serious TEAEs, and TEAEs experienced by at least 5% of participants in either treatment group
Entire study: approximately 82 weeks. (first dose of study drug until end of Safety Follow-up Visit at 28 +/- 7 days after the last dose (ie, 78-week treatment period plus 4-weeks follow-up after last dose up to total of 82 weeks)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Alzheon Inc.

Medewerkers

National Institute on Aging (NIA)

Onderzoekers

  • Hoofdonderzoeker: Susan Abushakra, MD, Alzheon Inc.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

19 mei 2021

Primaire voltooiing (Werkelijk)

29 mei 2024

Studie voltooiing (Werkelijk)

29 juli 2024

Studieregistratiedata

Eerst ingediend

22 februari 2021

Eerst ingediend dat voldeed aan de QC-criteria

22 februari 2021

Eerst geplaatst (Werkelijk)

25 februari 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 september 2026

Laatste update ingediend die voldeed aan QC-criteria

3 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ALZ-801-AD301
  • R01AG065253 (Subsidie/contract van de Amerikaanse NIH)
  • 2020-005755-20 (EudraCT-nummer)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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