Summary

Eligibility
for people ages 50-85 (full criteria)
Location
at UC Irvine
Dates
study started
study ends around
Principal Investigator
by Seyed Ahmad Sajjadi (uci)

Description

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.

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.

Details

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.

Keywords

Early Alzheimer's Disease, Alzheimer's Disease, Alzheimer Disease

Eligibility

You can join if…

Open to people ages 50-85

  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.

You CAN'T join if...

  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.

Locations

  • University of California
    Irvine California 92697 United States
  • Sutter Institute for Medical Research
    Sacramento California 95816 United States
  • Stanford University
    Palo Alto California 94304 United States

Lead Scientist at University of California Health

  • Seyed Ahmad Sajjadi (uci)
    Professor, Neurology, School of Medicine. Authored (or co-authored) 61 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cognition Therapeutics
ID
NCT05531656
Phase
Phase 2 Alzheimer's Disease Research Study
Study Type
Interventional
Participants
Expecting 540 study participants
Last Updated