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

Study on Investigational Medication for Early Alzheimer's Disease

J
Jared Brosch, MD

Primary Investigator

Enrolling By Invitation
18 years - 85 years
All
Phase N/A
2 participants needed
1 Location

Brief description of study

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.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Early Alzheimer's Disease
  • Age: 18 years - 85 years
  • Gender: All

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.

This study investigates the effects of an investigational medication on people with early Alzheimer's disease. Alzheimer's disease is a condition that affects memory and thinking skills. The purpose of this study is to learn more about the safety and effectiveness of the medication compared to a placebo, which is a substance that looks like the medication but does not contain any active medicine.

Participants will be randomly assigned to one of three study arms. They will receive either 100mg or 200mg of the investigational medication or a placebo. The medication or placebo will be taken as two capsules once a day. The study is double-blind, meaning neither the participants nor the researchers will know who is receiving the investigational medication or the placebo.

  • Who can participate: Individuals aged 50 to 85 years with early Alzheimer's disease can participate. Key eligibility includes having mild cognitive impairment or mild Alzheimer's dementia, an MMSE score between 20-30, and specific brain scan results consistent with Alzheimer's.
  • Study details: Participants will take two capsules of either the investigational medication or a placebo daily. Focus is on participant actions, with the study being randomized and double-blind.
  • Study timelines: The study will last 18 months.
Updated on 17 Sep 2025. Study ID: NEUR-USC-START, 23501
Please visit our main page to search for other studies you may be interested in. If you need help finding a study or have any questions, please contact us at inhealth@iu.edu

Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only