A Study to Evaluate Efficacy and Safety of Intravenous ACU193 in Participants With Early Alzheimer's Disease (ALTITUDE-AD) (ALTITUDE-AD)

March 28, 2024 updated by: Acumen Pharmaceuticals

A Phase 2/3 Double-Blind, Randomized, Placebo-Controlled Adaptive Design Trial to Evaluate the Efficacy and Safety of Intravenous ACU193 in Early Alzheimer's Disease

The primary purpose of this study is to evaluate the efficacy of ACU193 infusions administered once every four weeks (Q4W) in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2040

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada
        • Not yet recruiting
        • Okanagan Clinical Trials
      • Victoria, British Columbia, Canada
        • Not yet recruiting
        • Office of Alexandre Henri-Bhargava, MD
    • Ontario
      • London, Ontario, Canada
        • Not yet recruiting
        • Parkwood Institute
      • Ottawa, Ontario, Canada
        • Not yet recruiting
        • Hippocampe d/b/a Ottawa Memory Clinic
      • Peterborough, Ontario, Canada
        • Not yet recruiting
        • The Kawartha Regional Memory Clinic (KRMC)
      • Toronto, Ontario, Canada
        • Not yet recruiting
        • Baycrest - The Rotman Research Institute (RRI)
      • Toronto, Ontario, Canada
        • Not yet recruiting
        • Toronto Memory Program (TMP) (Neurology Research Inc.)
      • Toronto, Ontario, Canada
        • Not yet recruiting
        • University Health Network (UHN) - Toronto Western Hospital (TWH) - Krembil Neuroscience Centre (KNC) - Memory Clinic
    • Quebec
      • Greenfield Park, Quebec, Canada
        • Not yet recruiting
        • MoCA Research and Innovations
  • France
      • Amiens, France
        • Not yet recruiting
        • Amiens University Hospital
      • Bordeaux, France
        • Not yet recruiting
        • CHU Pellegrin
      • Bron, France
        • Not yet recruiting
        • Hôpital Neurologique Pierre Wertheimer
      • Marseille Cedex 05, France
        • Not yet recruiting
        • Hopital de la Timone
      • Montpellier, France
        • Not yet recruiting
        • CHU Montpellier
      • Paris, France
        • Not yet recruiting
        • Hopital Lariboisiere
      • Paris, France
        • Not yet recruiting
        • Institut de la Mémoire et de la Maladie d'Alzheimer -IM2A
      • Rennes, France
        • Not yet recruiting
        • CHU de Rennes, CMRR
      • Saint-Herblain, France
        • Not yet recruiting
        • CHU de NANTES-Hôpital Nord Laennec
      • Strasbourg, France
        • Not yet recruiting
        • Hôpitaux Universitaires de Strasbourg
      • Toulouse, France
        • Not yet recruiting
        • Centre de Recherche du Gérontopôle - CHU de Toulouse Hôpital la Grave
  • Germany
      • Berlin, Germany
        • Not yet recruiting
        • Charite - Universitaetsmedizin Berlin
      • Chemnitz, Germany
        • Not yet recruiting
        • Pharmakologisches Studienzentrum Chemnitz GmbH
      • Cologne, Germany
        • Not yet recruiting
        • University Hospital of Cologne
      • Homburg, Germany
        • Not yet recruiting
        • Saarland University Hospital
      • Mannheim, Germany
        • Not yet recruiting
        • Zentralinstitut für seelische Gesundheit
      • Munich, Germany
        • Not yet recruiting
        • Technical University of Munich, School of Medicine and Health, Klinikum rechts der Isar
      • Rostock, Germany
        • Not yet recruiting
        • Rostock University Medical Center
      • Westerstede, Germany
        • Not yet recruiting
        • Praxisgemeinschaft Dr. Springub/Schwarz
  • Italy
      • Cefalù, Italy
        • Not yet recruiting
        • Fondazione Istituto G. Giglio di Cefalù
      • Genova, Italy
        • Not yet recruiting
        • Policlinico San Martino
      • Milano, Italy
        • Not yet recruiting
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Monza, Italy
        • Not yet recruiting
        • Fondazione IRCCS San Gerardo dei Tintori
      • Perugia, Italy
        • Not yet recruiting
        • Neurology Clinic
      • Pozzilli, Italy
        • Not yet recruiting
        • IRCCS Neuromed
      • Roma, Italy
        • Not yet recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Roma, Italy
        • Not yet recruiting
        • Sapienza Università di Roma - AOU Policlinico Umberto I
      • Torino, Italy
        • Not yet recruiting
        • SSD Alzheimer's disease and related dementias
      • Tricase, Italy
        • Not yet recruiting
        • A.O. Piafondazione Card. G. Panico
  • Poland
      • Bydgoszcz, Poland
        • Not yet recruiting
        • Centrum Medyczne Neuromed
      • Krakow, Poland
        • Not yet recruiting
        • Krakowska Akademia Neurologii Sp. z o.o.
      • Pruszcz Gdanski, Poland
        • Not yet recruiting
        • NZOZ Syntonia
      • Sochaczew, Poland
        • Not yet recruiting
        • RCMed
      • Sopot, Poland
        • Not yet recruiting
        • Centrum Medyczne SENIOR
      • Warsaw, Poland
        • Not yet recruiting
        • Centrum Medyczne NeuroProtect
  • Spain
      • Barcelona, Spain
        • Not yet recruiting
        • Fundacio ACE
      • Cordoba, Spain
        • Not yet recruiting
        • Hospital Universitario Reina Sofia
      • Getxo, Spain
        • Not yet recruiting
        • CAE Oroitu
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Ruber
      • San Sebastian, Spain
        • Not yet recruiting
        • Policlinica Gipuzkoa
      • Sevilla, Spain
        • Not yet recruiting
        • Hospital Victoria Eugenia
      • Valencia, Spain
        • Not yet recruiting
        • Hospital Universitari I Politecnic La Fe
    • Barcelona
      • Sant Cugat Del Vallès, Barcelona, Spain
        • Not yet recruiting
        • Hospital Universitari General de Catalunya
    • Gipuzkoa
      • San Sebastián, Gipuzkoa, Spain
        • Not yet recruiting
        • Fundacion CITA alzheimer
    • Zaragoza
      • Cuarte de Huerva, Zaragoza, Spain
        • Not yet recruiting
        • Fundacion Neuropolis - Hospital Viamed Montecanal
  • United Kingdom
      • Bristol, United Kingdom
        • Not yet recruiting
        • Re:Cognition Health - Bristol
    • Devon
      • Plymouth, Devon, United Kingdom
        • Not yet recruiting
        • Re:Cognition Health - Plymouth
    • Greater London
      • Enfield Town, Greater London, United Kingdom
        • Not yet recruiting
        • Panthera Biopartners - Enfield
      • London, Greater London, United Kingdom
        • Not yet recruiting
        • Re:Cognition Health - London
      • London, Greater London, United Kingdom
        • Not yet recruiting
        • St. Pancras Clinical Research Ltd.
    • Greater Manchester
      • Rochdale, Greater Manchester, United Kingdom
        • Not yet recruiting
        • Panthera Bio-Partners - Rochdale
    • Hampshire
      • Winchester, Hampshire, United Kingdom
        • Not yet recruiting
        • Re:Cognition Health - Winchester
    • Lanarkshire
      • Motherwell, Lanarkshire, United Kingdom
        • Not yet recruiting
        • Neuroclin Glasgow
    • Lancashire
      • Preston, Lancashire, United Kingdom
        • Not yet recruiting
        • Panthera Bio-Partners - Preston
    • Surrey
      • Guildford, Surrey, United Kingdom
        • Not yet recruiting
        • Re:Cognition Health - Guildford
    • West Midlands
      • Birmingham, West Midlands, United Kingdom
        • Not yet recruiting
        • Re:Cognition Health - Birmingham
    • Yorkshire
      • Sheffield, Yorkshire, United Kingdom
        • Not yet recruiting
        • Panthera Biopartners - Sheffield
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Not yet recruiting
        • Banner Alzheimer's Institute- Clinical Trials Department
      • Phoenix, Arizona, United States, 85012
        • Not yet recruiting
        • IMA Clinical Research - Phoenix
    • California
      • Carlsbad, California, United States, 92011-4219
        • Not yet recruiting
        • The Neurology Center of Southern California - Carlsbad
      • Fullerton, California, United States, 92835
        • Not yet recruiting
        • Neurology Center of North Orange County
      • Irvine, California, United States, 92614
        • Not yet recruiting
        • Irvine Medical Research
      • Long Beach, California, United States, 90804
        • Not yet recruiting
        • Healthy Brain Research
      • San Diego, California, United States, 92123
        • Not yet recruiting
        • Sharp Mesa Vista Hospital
      • Santa Ana, California, United States, 92705
        • Not yet recruiting
        • Syrentis Clinical Research
      • Sherman Oaks, California, United States, 91403-2131
        • Not yet recruiting
        • CenExel - California Neuroscience Research Medical Group, Inc (CNR)
    • Colorado
      • Boulder, Colorado, United States, 80301-1880
        • Not yet recruiting
        • Alpine Clinical Research Center
      • Denver, Colorado, United States, 80218
        • Not yet recruiting
        • The Mile High Research Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510-3330
        • Not yet recruiting
        • Yale School of Medicine - Alzheimer's Disease Research Unit (ADRU)
      • Norwalk, Connecticut, United States, 06851-4903
        • Not yet recruiting
        • Research Center for Clinical Studies, LLC
    • District of Columbia
      • Washington, District of Columbia, United States, 22031
        • Not yet recruiting
        • Re:Cognition Health - Fairfax
    • Florida
      • Atlantis, Florida, United States, 33462
        • Recruiting
        • JEM Research Institute
        • Contact:
      • Bradenton, Florida, United States, 34205
        • Not yet recruiting
        • Bradenton Research Center
      • Coral Gables, Florida, United States, 33135
        • Not yet recruiting
        • Gil Fernandez-Yera, MD, PA
      • Delray Beach, Florida, United States, 33445
        • Not yet recruiting
        • Brain Matters Research
      • Homestead, Florida, United States, 33032
        • Not yet recruiting
        • Coral Clinical Research
      • Lady Lake, Florida, United States, 32159
        • Recruiting
        • K2 Medical Research - Villages
        • Contact:
      • Miami, Florida, United States, 33125
        • Not yet recruiting
        • Verus Clinical Research
      • Miami, Florida, United States, 33126
        • Not yet recruiting
        • Finlay Medical Research
      • Naples, Florida, United States, 34105-8522
        • Not yet recruiting
        • Collier Neurologic Specialists (CNS), L.L.C.
      • Ocala, Florida, United States, 34470
        • Not yet recruiting
        • Ocala Health - Family Care Specialists - Ocala I
      • Port Orange, Florida, United States, 32127
        • Not yet recruiting
        • Progressive Medical Research
      • Stuart, Florida, United States, 34997
        • Not yet recruiting
        • Alzheimer's Research and Treatment Center - Stuart
      • Tampa, Florida, United States, 33607
        • Not yet recruiting
        • K2 Medical Research - Tampa
      • The Villages, Florida, United States, 32162
      • Wellington, Florida, United States, 33414
        • Not yet recruiting
        • Alzheimers Research and Treatment Center - Wellington
      • Winter Park, Florida, United States, 32789
      • Winter Park, Florida, United States, 32792
        • Not yet recruiting
        • Charter Research - Winter Park
    • Georgia
      • Columbus, Georgia, United States, 31909
        • Not yet recruiting
        • Columbus Memory Center
      • Decatur, Georgia, United States, 30030
        • Not yet recruiting
        • Accel Research- Neurostudies
      • Decatur, Georgia, United States, 30030
        • Not yet recruiting
        • CenExel - iResearch Atlanta
      • Savannah, Georgia, United States, 31405
        • Not yet recruiting
        • CenExel - iResearch Savannah
    • Illinois
      • Northbrook, Illinois, United States, 60640
        • Not yet recruiting
        • Office of Jeffrey S. Ross, MD
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Not yet recruiting
        • KU Wichita Center for Clinical Research
    • Massachusetts
      • Methuen, Massachusetts, United States, 03801
        • Not yet recruiting
        • ActivMed Practices and Research
      • Newton, Massachusetts, United States, 02459
        • Not yet recruiting
        • Boston Center for Memory
      • Plymouth, Massachusetts, United States, 02360
        • Not yet recruiting
        • Donald S. Marks, MD. P.C.
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401-7246
        • Not yet recruiting
        • Hattiesburg Clinic - Memory Center
    • Nevada
      • Las Vegas, Nevada, United States, 89113-2215
        • Not yet recruiting
        • Las Vegas Medical Research Center
    • New Jersey
      • Princeton, New Jersey, United States, 08540-2859
        • Not yet recruiting
        • Princeton Psychiatric Center
      • Springfield, New Jersey, United States, 07081
        • Not yet recruiting
        • The Cognitive and Research Center of New Jersey
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • CenExel - Advanced Memory Research Institute of NJ
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Not yet recruiting
        • IMA Clinical Research - Albuquerque
    • New York
      • Albany, New York, United States, 12208
        • Not yet recruiting
        • Neurological Associates of Albany
      • New York, New York, United States, 10032
        • Not yet recruiting
        • Neurological Institute of New York
      • Syracuse, New York, United States, 13210-2342
        • Not yet recruiting
        • SUNY Upstate Medical University - Upstate University Hospital (SUNY Health Science Center)
    • North Carolina
      • Matthews, North Carolina, United States, 28105
        • Not yet recruiting
        • AMC Research
    • Ohio
      • Lakewood, Ohio, United States, 44107
        • Not yet recruiting
        • Cleveland Clinic - Lou Ruvo Center for Brain Health (CCLRCBH)
    • Oregon
      • Portland, Oregon, United States, 97210
        • Not yet recruiting
        • Summit Research Network
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Not yet recruiting
        • Abington Neurological Associates
      • Norristown, Pennsylvania, United States, 19462
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Not yet recruiting
        • Rhode Island Mood and Memory
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Not yet recruiting
        • Neurology Clinic. P.C
      • Knoxville, Tennessee, United States, 37920-1511
        • Not yet recruiting
        • The Alliance for Multispecialty Research LLC (AMR) - Knoxville (Volunteer Research Group)
    • Texas
      • Austin, Texas, United States, 78757
        • Not yet recruiting
        • Senior Adult Specialty Research
      • Beaumont, Texas, United States, 77702
        • Not yet recruiting
        • Gadolin Research, LLC
      • Dallas, Texas, United States, 75231
        • Not yet recruiting
        • Kerwin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Body weight of at least 30 kilograms (kg) (66 pounds [lbs]) and no more than 160 kg (352 lbs) at Screening
  • Must consent to apolipoprotein E4 (APOE4) genotype status assessment

  • Must meet all of the following criteria

    1. National Institute on Aging-Alzheimer's Association (NIA-AA) criteria for mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or probable AD
    2. Screening and baseline score between 22 and 30 (inclusive) on the Mini-Mental State Examination (MMSE)
    3. Screening score of 0.5 or 1.0 on the Clinical Dementia Rating Global Score (CDR-GS) and Screening score ≥0.5 on the CDR Memory Box score
    4. Evidence of cerebral amyloid accumulation by either PET scan or CSF
  • If using cholinesterase inhibitors or memantine to treat symptoms related to AD, doses must be stable for at least three months (12 weeks) prior to Baseline and every attempt should be made to keep them at stable doses throughout the study
  • Must have a reliable informant or study partner who is willing and able to perform all the roles as specified in the study partner Informed Consent Form (ICF)
  • Female participants must be surgically sterile or be at least one-year post-menopausal. Male participants with a female partner of child-bearing potential must use adequate contraception

Exclusion Criteria:

  • Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI
  • MRI of the brain that is inconsistent with MCI or AD or results showing greater than four ARIA-H, presence of any ARIA-E, or superficial siderosis
  • History of significant or unstable neurological disease, other than AD, which may affect cognition or ability to complete the study, such as other dementias, serious infection of the brain, significant head trauma, uncontrolled seizures, stroke, or Parkinson´s disease
  • Current serious or unstable clinically important illness that, in the judgment of the site investigator, is likely to affect cognitive assessment including visual and hearing impairment or affect the participant's safety or ability to complete the study
  • Malignant disease in the last five years except for resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal posttreatment prostate-specific antibody (PSA)
  • Geriatric Depression Scale-Short Form (GDS-SF) score >10 or current symptoms meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), criteria for major depressive disorder or any current primary psychiatric diagnosis other than AD if, in the judgment of the site investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessments, or affect the participant´s ability to complete the study

  • Suicide risk, as determined by meeting any of the following criteria:

    1. Any suicide attempt or preparatory acts/behavior on the C-SSRS Baseline/Screening in the last six months
    2. Suicidal ideation in the last six months as defined by a positive response to Question 5 (Suicidal Ideation) on the C-SSRS Baseline/Screening
    3. Significant risk of suicide, as judged by the site investigator
  • Conditions that may affect cognitive assessments during the study
  • Alcohol use disorder and/or substance use disorder within the last five years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Double-blind Treatment (DBT) Period: ACU193 35 mg/kg
Participants will receive ACU193, 35 milligrams per kilogram (mg/kg), Q4W as intravenous (IV) infusion during the DBT period.
Drug: ACU193
Intravenous ACU193
Experimental: DBT Period: ACU193 50 mg/kg
Participants will receive ACU193, 35 mg/kg, for the first two doses, followed by AUC193, 50 mg/kg, Q4W as an IV infusion during the DBT period.
Drug: ACU193
Intravenous ACU193
Placebo Comparator: DBT Period: Placebo
Participants will receive AUC193 matching placebo, Q4W as an IV infusion during the DBT period.
Drug: Placebo
Intravenous Placebo
Experimental: Open-Label Extension (OLE) Period: ACU193 35 mg/kg
Participants will receive ACU193, 35 mg/kg, Q4W as an IV infusion during the OLE period.
Drug: ACU193
Intravenous ACU193

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score
Time Frame: Baseline up to Week 80
iADRS is a validated composite of cognition and function made up of Alzheimer's Disease Assessment Scale - Cognitive Subscale 13-item (ADAS-Cog13) and the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living scale (ADCS-iADL). ADAS-Cog13 is a rater-administered instrument consisting of 13 items assessing cognitive function areas most typically impaired in AD. ADAS-Cog13 scores range from 0 to 85, with higher scores indicating a greater deficit of global cognition. The ADCS-iADL is a subset of the 23-item ADCS-ADL (items 6a and 7 to 23). The iADLs are more complex skills required to successfully live independently. iADL-items score ranges from 0 to 59 (lower scores indicating greater impairment). The iADRS is calculated as a linear combination of total scores from the ADAS-Cog13 and ADCS-iADL. The iADRS score ranges from 0 to 144 with lower scores indicating worse performance.
Baseline up to Week 80

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in ADCS-iADL Score
Time Frame: Baseline up to Week 80
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire to be answered by a participant's study partner, where a participant's performance level is rated over the last 4 weeks, based on a set of performance descriptions. The ADCS-iADL is a subset of the 23-item ADCS-ADL (items 6a and 7 to 23). The iADLs are more complex skills required to successfully live independently, and include shopping, keeping appointments, traveling outside of the home, making a meal or snack, and reading and writing. The iADL-items score ranges from 0 to 59 with lower scores indicating greater impairment.
Baseline up to Week 80
Change from Baseline in ADAS-Cog13 Score
Time Frame: Baseline up to Week 80
ADAS-Cog is a rater-administered instrument, designed to assess the severity of dysfunction in cognition, characteristic of persons with AD. The ADAS-Cog13, the cognitive subscale of the ADAS, consists of 13 items assessing cognitive function areas most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, and digit cancellation. The scores range from 0 to 85, with higher scores indicating a greater deficit of global cognition.
Baseline up to Week 80
Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Time Frame: Baseline up to Week 80
The CDR is obtained through semi-structured interviews of individuals with AD and informants. The ratings are obtained in six domains: memory, orientation, judgment & problem-solving, community affairs, home & hobbies, and personal care. Each domain is rated on a five-point scale of functioning as follows: 0 = no impairment; 0.5 = questionable impairment; 1 = mild impairment; 2 = moderate impairment; and 3 = severe impairment. CDR-SB score is obtained by summing each of the domain scores, with scores ranging from 0 to 18. Higher scores reflect greater cognitive and functional impairment.
Baseline up to Week 80
Change from Baseline in Mini-Mental State Examination (MMSE)
Time Frame: Baseline up to Week 80
MMSE is a standard staging and assessment tool in AD, designed for grading the cognitive state of individuals with AD. The scale comprises tasks concerning orientation, memory, attention, language, and praxis to evaluate an individual's cognitive state. MMSE total score ranges from 0 to 30, with lower scores indicative of greater cognitive impairment.
Baseline up to Week 80
Change from Baseline in Quality of Life in Alzheimer's Disease (QoL-AD)
Time Frame: Baseline up to Week 80
The QOL-AD tool is a 13-item assessment with each question scored on a 4-point scale where 1 = poor quality of life and 4 = excellent quality of life. Scores range from 13 to 52 with higher scores indicating better quality of life.
Baseline up to Week 80
Change from Baseline in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score
Time Frame: Baseline up to Week 80
NPI-Q is a validated questionnaire completed by informants about participants for whom they care. Each of the 12 NPI-Q domains contains a survey question (answered in Yes/No) that reflects the cardinal symptoms of that domain. If the domain response is "Yes," the informant then rates the severity of the symptoms present within the last month on a 3-point scale and the distress of the symptom using a 5-point scale. The total NPI-Q severity score is the sum of the individual severity scores for each symptom and ranges from 0 to 36, with higher scores indicating more severe behavioral impairment. The total NPI-Q distress score is the sum of the individual distress scores for each symptom and ranges from 0 to 60, with higher scores indicating greater caregiver distress.
Baseline up to Week 80
Change from Baseline in EuroQoL 5-Dimension 5-Level (EQ-5D-5L)
Time Frame: Baseline up to Week 80
EQ-5D-5L is a self-report survey that measures quality of life. The EQ-5D-5L consists of an EQ-5D descriptive system and EQ visual analog scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, each assigned a unique 1-digit number: no problems, slight problems, moderate problems, severe problems, and extreme problems. The digits are combined into a 5-digit number that describes the participant's health state. The EQ VAS records the participant's health on a vertical visual analog scale, where the endpoints are labeled 0= the best health you can imagine, and 100= the worst health you can imagine.
Baseline up to Week 80
Change from Baseline in Resource Utilization in Dementia (RUD)
Time Frame: Baseline up to Week 80
The RUD questionnaire is a standardized tool and the most widely used instrument for resource use data collection in dementia, enabling comparison of costs of care across countries with differing health care provisions. It is designed to collect data on formal and informal care resource use and to be useful in different care settings, across different countries and care systems, and in both clinical studies and observational cost-of-illness studies.
Baseline up to Week 80
Change from Baseline in Zarit Burden Interview (ZBI)
Time Frame: Baseline up to Week 80
ZBI consists of 22 items. Twenty-one of the items are designed to measure several aspects of burden, whereas Item 22 is a global measure of burden. Response options for each item range from 0-4, and total scores range from 0-88, with higher scores indicating greater self-reported burden.
Baseline up to Week 80
Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by iADRS
Time Frame: Baseline up to Week 80
Baseline up to Week 80
Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by ADCS-iADL
Time Frame: Baseline up to Week 80
Baseline up to Week 80
Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by ADAS-Cog13
Time Frame: Baseline up to Week 80
Baseline up to Week 80
Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by CDR-SB
Time Frame: Baseline up to Week 80
Baseline up to Week 80
Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by MMSE
Time Frame: Baseline up to Week 80
Baseline up to Week 80
Percentage of Participants with No Clinical Progression at One Year
Time Frame: Baseline up to Week 80
No clinical progression in participants will be defined as no decline in CDR-SB score. The CDR is obtained through semi-structured interviews of individuals with AD and informants. The ratings are obtained in six domains: memory, orientation, judgment & problem-solving, community affairs, home & hobbies, and personal care. Each domain is rated on a five-point scale of functioning as follows: 0 = no impairment; 0.5 = questionable impairment; 1 = mild impairment; 2 = moderate impairment; and 3 = severe impairment. CDR-SB score is obtained by summing each of the domain scores, with scores ranging from 0 to 18. Higher scores reflect greater cognitive and functional impairment.
Baseline up to Week 80
Number of Participants with Treatment-Related Adverse Events (TEAEs)
Time Frame: Baseline up to Week 80
Baseline up to Week 80
Number of Participants with Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
Time Frame: Baseline up to Week 80
Baseline up to Week 80
Number of Participants who Discontinue or Withdraw due to TEAE
Time Frame: Baseline up to Week 80
Baseline up to Week 80
Number of Participants with Anti-Drug Antibodies (ADA) and Neutralizing Antibodies
Time Frame: Baseline up to Week 80
Baseline up to Week 80
Number of Participants with Amyloid-Related Imaging Abnormality with Edema/Effusions (ARIA-E) and ARIA with Hemorrhage/Hemosiderin Deposition (ARIA-H) as Measured by Magnetic Resonance Imaging (MRI)
Time Frame: Baseline up to Week 80
Baseline up to Week 80
Number of Participants with Suicidal Ideation and Behavior as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: Baseline up to Week 80
The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.
Baseline up to Week 80
Serum Concentration of ACU193
Time Frame: Pre-dose and multiple timepoints post dose up to 80 weeks
Pre-dose and multiple timepoints post dose up to 80 weeks
Concentration of ACU193 in Cerebrospinal Fluid (CSF)
Time Frame: Up to Week 76
Up to Week 76
CSF Concentrations of ACU193 in a Subset of Participants
Time Frame: Up to Week 76
Up to Week 76
Correlation Between ACU193 Exposure with Clinical Efficacy Measures
Time Frame: Baseline up to 80 weeks
Correlation between ACU193 exposure and clinical outcomes (including iADRS, CDR-SB, ADCS-iADL, ADAS-Cog13, and MMSE) will be assessed in this study.
Baseline up to 80 weeks
Change From Baseline in Amyloid Plaque Load or Deposition Measured by Positron Emission Tomography (PET) in Centiloids
Time Frame: Baseline up to Week 76
Baseline up to Week 76
Change from Baseline in Volumetric Magnetic Resonance Imaging (vMRI) of Whole Brain Volume, Ventricular Volume, and Volume of Selected Regions of Interest
Time Frame: Baseline up to Week 76
Baseline up to Week 76
Target Engagement Assessed by Measurement of ACU193- Amyloid-β oligomer (AβO) Complex in CSF
Time Frame: Up to Week 76
Up to Week 76
Change from Baseline in CSF Concentrations of Amyloid, Tau and Other Neurodegenerative Biomarkers
Time Frame: Baseline up to Week 76
Baseline up to Week 76
Change from Baseline in CSF Concentrations of Amyloid, Tau, and Other Neurodegenerative Biomarkers in a Subset of Participants
Time Frame: Baseline up to Week 76
Baseline up to Week 76
Change from Baseline in Blood Concentrations of Amyloid, Tau, and Other Neurodegenerative Biomarkers
Time Frame: Baseline up to Week 76
Baseline up to Week 76
Correlation Between Change in Biomarker that Reflect Disease Progression and Clinical Changes
Time Frame: Up to 80 weeks
Assessment of the correlation between change in clinical outcomes (iADRS, CDR-SB, ADCS-iADL, ADAS-Cog13, and MMSE) and change in biomarker (amyloid PET) will be determined by computing Pearson's correlation coefficient for each treatment group.
Up to 80 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acumen Pharmaceuticals

Investigators

  • Principal Investigator: Eric Siemers, MD, Acumen Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 29, 2024

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

January 1, 2031

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACU193-201
  • 2023-509807-34-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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