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En studie av effektivitet og sikkerhet av ALZ-801 i APOE4/4 tidlige AD-emner (APOLLOE4)

3. september 2026 oppdatert av: Alzheon Inc.

En fase 3, multisenter, randomisert, dobbeltblind, placebokontrollert studie av effektivitet, sikkerhet og biomarkøreffekter av ALZ-801 hos personer med tidlig Alzheimers sykdom og 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

325

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

50 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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).
Legemiddel: 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

Andre navn:
  • Valiltramiprosate
  • Tramiprosate prodrug
Legemiddel: Placebo Comparator: Placebo

Placebo tablet BID
Placebo komparator: Placebo

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

Placebo tablet BID

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Primary Cognitive Efficacy Endpoint (ADAS-Cog13)
Tidsramme: 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)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Key Secondary Endpoint (A-IADL-W)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Imaging Biomarker Endpoint (Hippocampal Volume)
Tidsramme: 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])
Tidsramme: 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])
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Alzheon Inc.

Samarbeidspartnere

National Institute on Aging (NIA)

Etterforskere

  • Hovedetterforsker: Susan Abushakra, MD, Alzheon Inc.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

19. mai 2021

Primær fullføring (Faktiske)

29. mai 2024

Studiet fullført (Faktiske)

29. juli 2024

Datoer for studieregistrering

Først innsendt

22. februar 2021

Først innsendt som oppfylte QC-kriteriene

22. februar 2021

Først lagt ut (Faktiske)

25. februar 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ALZ-801-AD301
  • R01AG065253 (U.S. NIH-stipend/kontrakt)
  • 2020-005755-20 (EudraCT-nummer)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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