Effect of CT1812 Treatment on Brain Synaptic Density

NCT03493282 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: COG0105RF1AG057553
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Study to Evaluate the Safety and Tolerability of Oral CT1812 in Subjects with Mild to Moderate Alzheimer's Disease.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Number of TEAEs, Related TEAEs, SAEs, and Related SAEs

  Number of subjects reported with AEs and the number of AEs reported following administration of the IP summarized by treatment and grouped according to system organ class and preferred term, using descriptive statistics. Summaries of AEs were also presented by severity and by relationship to investigational product. In these summaries, subjects were counted only once per MedDRA term, for the AE of highest severity or least favorable relationship. Summaries were also presented of SAEs and of AEs leading to study withdrawal.

  Up to 12 months

Secondary Outcomes (16)

• Change From Baseline in the Imaging of [11C] UCB-J PET Distribution Volume Ratio (DVR)

  Day 169

• Change From Baseline in the Imaging of [18F]FDG PET SUV Ratio (SUVR)

  Day 169

• Change From Baseline in Volumetric Magnetic Resonance Imaging (MRI)

  Day 169

• Change From Baseline in the Imaging of Functional MRI - Intrinsic Connectivity Contrast (ICC)

  Day 169

• Change From Baseline in the Cerebrospinal Fluid (CSF) Biomarkers

  Day 169

Study Arms (3)

300 mg

ACTIVE COMPARATOR

High Dose CT1812

Drug: Active Treatment- CT1812 300 mg

100 mg

ACTIVE COMPARATOR

Low Dose CT1812

Drug: Active Treatment- CT1812 100 mg

Placebo

PLACEBO COMPARATOR

Matching Placebo

Drug: Placebo

Interventions

Active Treatment- CT1812 100 mg DRUG

CT1812

100 mg

Active Treatment- CT1812 300 mg DRUG

CT1812

300 mg

Placebo DRUG

Matching Placebo

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants may be included in the study only if they meet all of the following criteria:
• Men, and women of non-childbearing potential, 50-85 years of age inclusively, with a diagnosis of mild to moderate Alzheimer's disease according to the 2011 NIA-AA criteria and at least a 6 month decline in cognitive function documented in the medical record.
• Non-childbearing potential for women is defined as postmenopausal \[last natural menses greater than 24 months; in women under age 55, menopausal status will be documented with serum follicle stimulating hormone (FSH) test\] or undergone a documented bilateral tubal ligation or hysterectomy.
• Male participants who are sexually active with a woman of child-bearing potential must agree to use condoms during the trial and for 3 months after last dose unless the woman is using an acceptable means of birth control. Acceptable forms of birth control include abstinence, birth control pills, or any double combination of: intrauterine device (IUD), male or female condom, diaphragm, sponge, and cervical cap.

You may not qualify if:

• MMSE 18-26 inclusive
• A positive amyloid (Pittsburgh imaging compound B) scan at screening, or history of a positive amyloid scan prior to study entry, or prior lumbar puncture with a CSF Abeta concentration consistent with Alzheimer's disease.
• Formal education of eight or more years.
• Must have a caregiver who sees them at least 10 hours per week, oversees the administration of study drug, and is willing and able to oversee administration of study medication and participate in all clinic visits and some study assessments. The caregiver must provide written informed consent to participate in the study.
• Living at home or in the community (assisted living acceptable)
• Able to swallow CT1812 capsules.
• Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening.
• Capable of providing either written informed consent or oral assent to the study procedures and for use of protected health information \[Health Insurance Portability and Accountability Act (HIPAA) Authorization, if applicable\]. If the Participant can provide only assent, their legally authorized representative also must provide written informed consent. Written informed consent also shall be obtained from the responsible caregiver. All consent processes must be undertaken in the presence of a witness and prior to any study procedures.
• Must consent to apolipoprotein E (ApoE) genotyping.
• Generally healthy with mobility (ambulatory or ambulatory-aided, i.e., walker or cane), vision and hearing (hearing aid permissible) sufficient for compliance with testing procedures.
• Able to complete all screening evaluations.
• Participants will be excluded from the study if any of the following conditions apply:
• Hospitalization or change of chronic concomitant medication within one month prior to screening.
• Patients living in a continuous care nursing facility
• Screening MRI of the brain indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct \> 1 cm3, \>3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor such as meningioma).

Sponsors & Collaborators

• Cognition Therapeutics: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• van Dyck CH, Mecca AP, O'Dell RS, Bartlett HH, Diepenbrock NG, Huang Y, Hamby ME, Grundman M, Catalano SM, Caggiano AO, Carson RE. A pilot study to evaluate the effect of CT1812 treatment on synaptic density and other biomarkers in Alzheimer's disease. Alzheimers Res Ther. 2024 Jan 25;16(1):20. doi: 10.1186/s13195-024-01382-2.

  PMID: 38273408 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Chief Medical Officer, Head of R&D
• Organization: Cogntion Therapeutics Inc

acaggiano@cogrx.com

914-221-6730

Study Officials

• Christopher van Dyck, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: April 10, 2018
• Study Start: March 28, 2018
• Primary Completion: October 16, 2020
• Study Completion: October 16, 2020
• Last Updated: September 7, 2023
• Results First Posted: March 1, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)