Evaluating CT1812 for early Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled Phase 2 study aims to assess the safety, efficacy, and tolerability of two doses of CT1812 in participants diagnosed with early Alzheimer's disease. Approximately 540 participants will be enrolled and randomized to receive either 100mg or 200mg of CT1812 or a placebo, taken orally once daily for 18 months. The study will utilize rigorous diagnostic criteria, including amyloid PET scans and neuroimaging, to ensure accurate participant selection.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Banner Alzheimer's Institute
  Phoenix, Arizona, United States Recruiting
• Banner Sun Health Research Institute
  Sun City, Arizona, United States Recruiting
• University of California
  Irvine, California, United States Recruiting
• Stanford University
  Palo Alto, California, United States Recruiting
• Yale University
  New Haven, Connecticut, United States Recruiting

Study contacts

• Study coordinator: Theresa Devins, DrPH, MS
• Email: clinicaltrials@cogrx.com
• Phone: 888-745-1050

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.