Home › Trials › NCT05531656

Evaluating CT1812 for early Alzheimer's disease

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.

Phase 2 Interventional Cognition Therapeutics · NCT05531656

This study is testing if a new medication called CT1812 can help people with early Alzheimer's disease feel better and tolerate the treatment over 18 months.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment540 (estimated)
Ages50 Years to 85 Years
SexAll
SponsorCognition Therapeutics Industry-sponsored
Locations46 sites (Birmingham, Alabama and 45 other locations)
Trial IDNCT05531656 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 50-85 with a diagnosis of mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia.

Not a fit: Patients with significant abnormalities in brain MRI or those with other primary degenerative dementias or neurodegenerative conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for individuals with early Alzheimer's disease, potentially slowing disease progression.

How similar studies have performed: Other studies targeting early Alzheimer's disease have shown promise, but the specific approach of CT1812 is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 45 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Early Alzheimer's DiseaseAlzheimer's Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.