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A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT05531656
Recruitment Status : Recruiting
First Posted : September 8, 2022
Last Update Posted : May 9, 2024
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Alzheimer's Clinical Trials Consortium
Information provided by (Responsible Party):
Cognition Therapeutics

Study Description
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Brief Summary:
This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo in participants diagnosed with early Alzheimer's disease.

Condition or disease Intervention/treatment Phase
Early Alzheimer's Disease Drug: CT1812 Drug: Placebo Phase 2

Detailed Description:

This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo for approximately 18 months (72 weeks) in approximately 540 participants diagnosed with early Alzheimer's disease

Participants will be randomized 1:1:1 to receive either 100mg or 200mg of CT1812 or placebo. CT1812 or placebo will be administered as 2 capsules to be taken orally once daily.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Synaptic Therapy Alzheimer's Research Trial (START): A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease Over 18 Months.
Actual Study Start Date : June 28, 2023
Estimated Primary Completion Date : April 2027
Estimated Study Completion Date : April 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: CT1812 100 mg
CT1812 at a dose of 100 n=180 group
 Drug: CT1812
Study Drug
Other Name: Study Drug Active
Active Comparator: CT1812 200 mg
CT1812 at a dose of 300mg, n=180 group
 Drug: CT1812
Study Drug
Other Name: Study Drug Active
Placebo Comparator: Placebo
Placebo, n=180 group
 Drug: Placebo
Non-active study drug
Other Name: Matching Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scale. [ Time Frame: 18 months ]
    The Clinical Dementia Rating (CDR) is a clinical scale that describes 5 levels of impairment in performance on each of 6 categories of function including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The ratings of degree of impairment obtained on each of the 6 categories of function are synthesized into 1 global rating of dementia as absent, questionable, mild, moderate, or severe (global CDR scores of 0, 0.5, 1, 2, or 3, respectively). The score is based on interviews with the participant and study partner, using a structured interview. A sum of boxes score (CDR-SB) provides an additional measure of change where each category has a maximum possible score of 3 points and the total score is a sum of the category scores giving a total possible score of 0 to 18 with higher scores indicating more impairment.


Secondary Outcome Measures :
  1. Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13) [ Time Frame: 18 months ]
    Change from baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13) at 18 months.

  2. Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS - ADL) in people with Mild Cognitive Impairment (MCI) - ADCS-ADL-MCI. [ Time Frame: 18 months ]
    Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS - ADL) in people with Mild Cognitive Impairment (MCI) - ADCS-ADL-MCI at 18 months.

  3. Cerebrospinal fluid (CSF) concentrations of beta-amyloid (Aβ) 40 and 42, tau, phospho-tau (ptau), neurofilament light (NfL), neurogranin, and synaptotagmin. [ Time Frame: 18 months ]
    Change from baseline at 18 months.

  4. Plasma measures of Aβ fragments, ptau, and Neurofilament light (NfL) [ Time Frame: 18 months ]
    Change from baseline at 18 months.

  5. Volumetric Magnetic Resonance Imaging (MRI) including hippocampal and whole brain volume change [ Time Frame: 18 months ]
    Change from baseline at 18 months.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ages 50-85 years.
  2. Diagnosis of either MCI due to AD or mild AD dementia.
  3. MMSE 20-30 (inclusive).
  4. Amyloid PET scan of the brain or CSF biomarkers consistent with AD.
  5. Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer's disease, as based on central read.

Exclusion Criteria:

  1. Screening MRI of the brain indicative of significant abnormality.
  2. Clinically significant abnormalities in screening laboratory tests.

  3. Clinical or laboratory findings consistent with:

    1. Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
    2. Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.).
    3. Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12, other laboratory values etc.)
  4. A participant known to be actively infected with hepatitis B or hepatitis C at screening. History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for hepatitis B surface antigen [HbsAg] or anti-hepatitis C [HCV] antibody). Participants who have evidence of resolved hepatitis infection (e.g., HCV RNA negative) may be considered following discussion with the Medical Monitor.
  5. A current DSM-V diagnosis of active major depression or GDS > 6, schizophrenia, or bipolar disorder.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05531656


Contacts
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Contact: Diana Executive Assistant 888-745-1050 clinicaltrials@cogrx.com

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Principal Investigator: David Geldmacher         
United States, California
University of California Recruiting
Irvine, California, United States, 92697
Principal Investigator: S. Ahmad Sajjadi         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06510
Principal Investigator: Ryan O'Dell         
United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20057
Principal Investigator: Raymond Scott Turner         
Howard University Not yet recruiting
Washington, District of Columbia, United States, 20060
Principal Investigator: Thomas Obisesan         
United States, Florida
Mayo Clinic,Jacksonville Not yet recruiting
Jacksonville, Florida, United States, 32216
Principal Investigator: Neill Graff-Radford         
University of South Florida Recruiting
Tampa, Florida, United States, 33613
Principal Investigator: Ram Bishnoi         
United States, Kentucky
Sanders-Brown Center on Aging Recruiting
Lexington, Kentucky, United States, 40504
Principal Investigator: Gregory Jicha, MD, PhD         
United States, Massachusetts
Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Seth Gale         
United States, Minnesota
Mayo Clinic, Rochester Recruiting
Rochester, Minnesota, United States, 55901
Principal Investigator: Jonathan Graff-Radford         
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Principal Investigator: Suzanne Craft         
United States, Oregon
Oregon Health & Science University Not yet recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Aimee Pierce         
United States, Pennsylvania
Abington Neurological Associates Not yet recruiting
Abington, Pennsylvania, United States, 19001
Principal Investigator: David Weisman         
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Sanjeev Vaishnavi         
United States, Rhode Island
Butler Hospital Recruiting
Providence, Rhode Island, United States, 02906
Principal Investigator: Meghan Riddle         
Sponsors and Collaborators
Cognition Therapeutics
National Institute on Aging (NIA)
Alzheimer's Clinical Trials Consortium
Investigators
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Study Director: Anthony Caggiano, MD Cognition Therapeutics
More Information
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Responsible Party: Cognition Therapeutics
ClinicalTrials.gov Identifier: NCT05531656    
Other Study ID Numbers: COG0203
R01AG065248 ( U.S. NIH Grant/Contract )
First Posted: September 8, 2022    Key Record Dates
Last Update Posted: May 9, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cognition Therapeutics:
Alzheimer's Disease
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders