ACTIVE_NOT_RECRUITING

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

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Conditions

Early Alzheimer's DiseaseAlzheimer's Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 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.

Quick Facts

Study Start:2023-06-28
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05531656

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Ages 50-85 years.
  2. 2. Diagnosis of either MCI due to AD or mild AD dementia.
  3. 3. MMSE 20-30 (inclusive).
  4. 4. Amyloid PET scan of the brain or CSF biomarkers consistent with AD.
  5. 5. Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer's disease, as based on central read.
  1. 1. Screening MRI of the brain indicative of significant abnormality.
  2. 2. Clinically significant abnormalities in screening laboratory tests.
  3. 3. Clinical or laboratory findings consistent with:
  4. 1. Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
  5. 2. Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.).
  6. 3. Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12, other laboratory values etc.)
  7. 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.
  8. 5. A current DSM-V diagnosis of active major depression or GDS \> 6, schizophrenia, or bipolar disorder.

Contacts and Locations

Principal Investigator

Anthony Caggiano, MD
STUDY_DIRECTOR
Cognition Therapeutics

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
United States
Banner Sun Health Research Institute
Sun City, Arizona, 85351
United States
University of California
Irvine, California, 92697
United States
Stanford University
Palo Alto, California, 94304
United States
Sutter Institute for Medical Research
Sacramento, California, 95816
United States
Yale University
New Haven, Connecticut, 06510
United States
Georgetown University
Washington D.C., District of Columbia, 20057
United States
Howard University
Washington D.C., District of Columbia, 20060
United States
Brain Matters Research
Delray Beach, Florida, 33445
United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912
United States
Mayo Clinic,Jacksonville
Jacksonville, Florida, 32216
United States
JEM Research Institute
Lake Worth, Florida, 33462
United States
K2 Medical Research, LLC
Maitland, Florida, 32751
United States
Advanced Clinical Research Network, Corp
Miami, Florida, 33135
United States
Charter Research
Orlando, Florida, 32803
United States
Headlands Research Orlando
Orlando, Florida, 32819
United States
Brain Matters Research Stuart
Stuart, Florida, 34997
United States
University of South Florida
Tampa, Florida, 33613
United States
Conquest Research, LLC
Winter Park, Florida, 32789
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Indiana University
Indianapolis, Indiana, 46202
United States
Sanders-Brown Center on Aging
Lexington, Kentucky, 40504
United States
John Hopkins University
Baltimore, Maryland, 21224
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Highlands Research Eastern MA
Plymouth, Massachusetts, 02360
United States
University of Michigan, Ann Arbor
Ann Arbor, Michigan, 48109
United States
Mayo Clinic, Rochester
Rochester, Minnesota, 55901
United States
Washington University School of Medicine
St Louis, Missouri, 63110
United States
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106
United States
Mount Sinai School of Medicine
New York, New York, 10029
United States
Columbia University Medical Center
New York, New York, 10032
United States
University of Rochester Medical Center
Rochester, New York, 14620
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States
Case Western Reserve University / University Hospitals
Beachwood, Ohio, 44122
United States
Ohio State University
Columbus, Ohio, 43210
United States
Central States Research, LLC
Tulsa, Oklahoma, 74136
United States
Summit Headlands LLC
Portland, Oregon, 97210
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
Abington Neurological Associates
Abington, Pennsylvania, 19001
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Butler Hospital
Providence, Rhode Island, 02906
United States
Ralph H. Johnson VA MC
Charleston, South Carolina, 29401
United States
Vanderbilt University Medical Center Center for Cognitive Medicine
Nashville, Tennessee, 37212
United States
Vanderbilt University Medical Center Center for Cognitive Medicine
Nashville, Tennessee, 37232
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Houston Methodist Neurological Institute
Houston, Texas, 77030
United States
University of Texas Health Science Center
San Antonio, Texas, 78229
United States
University of Wisconsin
Madison, Wisconsin, 53726
United States

Collaborators and Investigators

Sponsor: Cognition Therapeutics

  • Anthony Caggiano, MD, STUDY_DIRECTOR, Cognition Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-28
Study Completion Date2027-04

Study Record Updates

Study Start Date2023-06-28
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

  • Alzheimer's Disease

Additional Relevant MeSH Terms

  • Early Alzheimer's Disease