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

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Cognition Therapeutics

Status and phase

Enrolling
Phase 2

Conditions

Early Alzheimer's Disease

Treatments

Drug: Placebo
Drug: CT1812

Study type

Interventional

Funder types

Other
Industry
NIH

Identifiers

NCT05531656
COG0203
R01AG065248 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

540 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

540 participants in 3 patient groups, including a placebo group

CT1812 100 mg
Active Comparator group
Description:
CT1812 at a dose of 100 n=180 group
Treatment:
Drug: CT1812
CT1812 200 mg
Active Comparator group
Description:
CT1812 at a dose of 300mg, n=180 group
Treatment:
Drug: CT1812
Placebo
Placebo Comparator group
Description:
Placebo, n=180 group
Treatment:
Drug: Placebo

Trial contacts and locations

15

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Central trial contact

Diana Executive Assistant

Data sourced from clinicaltrials.gov

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