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

Early Alzheimer's Disease Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05531656
• Other study ID #: COG0203
• Secondary ID: R01AG065248
• Status: Recruiting
• Phase: Phase 2
• Start date: June 28, 2023
• Est. completion date: April 2027

Study information

• Verified date: May 2024
• Source: Cognition Therapeutics
• Contact: Diana Executive Assistant
• Phone: 888-745-1050
• Email: clinicaltrials[@]cogrx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Early Alzheimer's Disease

Intervention

Drug:
• CT1812
Study Drug
• Placebo
Non-active study drug

Locations

Country	Name	City	State
United States	Abington Neurological Associates	Abington	Pennsylvania
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of California	Irvine	California
United States	Mayo Clinic,Jacksonville	Jacksonville	Florida
United States	Sanders-Brown Center on Aging	Lexington	Kentucky
United States	Yale University	New Haven	Connecticut
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Butler Hospital	Providence	Rhode Island
United States	Mayo Clinic, Rochester	Rochester	Minnesota
United States	University of South Florida	Tampa	Florida
United States	Georgetown University	Washington	District of Columbia
United States	Howard University	Washington	District of Columbia
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Cognition Therapeutics	Alzheimer's Clinical Trials Consortium, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scale.	The Clinical Dementia Rating (CDR) is a clinical scale that describes 5 levels of impairment in performance on each of 6 categories of function including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The ratings of degree of impairment obtained on each of the 6 categories of function are synthesized into 1 global rating of dementia as absent, questionable, mild, moderate, or severe (global CDR scores of 0, 0.5, 1, 2, or 3, respectively). The score is based on interviews with the participant and study partner, using a structured interview. A sum of boxes score (CDR-SB) provides an additional measure of change where each category has a maximum possible score of 3 points and the total score is a sum of the category scores giving a total possible score of 0 to 18 with higher scores indicating more impairment.	18 months
Secondary	Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13)	Change from baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13) at 18 months.	18 months
Secondary	Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS - ADL) in people with Mild Cognitive Impairment (MCI) - ADCS-ADL-MCI.	Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS - ADL) in people with Mild Cognitive Impairment (MCI) - ADCS-ADL-MCI at 18 months.	18 months
Secondary	Cerebrospinal fluid (CSF) concentrations of beta-amyloid (Aß) 40 and 42, tau, phospho-tau (ptau), neurofilament light (NfL), neurogranin, and synaptotagmin.	Change from baseline at 18 months.	18 months
Secondary	Plasma measures of Aß fragments, ptau, and Neurofilament light (NfL)	Change from baseline at 18 months.	18 months
Secondary	Volumetric Magnetic Resonance Imaging (MRI) including hippocampal and whole brain volume change	Change from baseline at 18 months.	18 months