Pilot Clinical Study of CT1812 in Mild to Moderate Alzheimer's Disease Using EEG

NCT04735536 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: COG0202RF1AG0587102019-003552-36
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-site, randomized, double-blind, placebo-controlled, 29-day, 2-period crossover Phase 2 study of 1 dose level of CT1812 (active) or placebo in adults with mild to moderate AD.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (3)

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

  Adverse events were captured from the start of study-related procedures at Visit 1 (including diagnostic assessments or signing of ICF) onward during the course of this study. Adverse events were coded using MedDRA Version 22.0

  Up to 126 days

• Change in the Brain Activity Reflected by Changes of Spectral Power in Conventional Frequency Bands Measured by the Global Relative Theta (4-8 Hz) Power Obtained Through EEG Assessment.

  Global relative theta power was quantified and summarized descriptively (observed values, change from the pre-treatment values) by treatment and time point using the Safety Population. The change from period baseline in global relative theta power within each period was analyzed using a linear mixed model with fixed effects for treatment group (CT1812 or placebo), sequence, and period, and a random effect for subject within sequence. The analysis was conducted using PROC MIXED. The ability of CT1812 to rapidly restore synapse number to normal was expected to result in a decrease in EEG theta power in AD patients in response to short-term treatment with CT1812. Thus, a decrease in the Global Relative Theta Power represents better outcomes, while high values in the Global Relative Theta Power represent worse outcomes. The unit is represented by uV\^2/Hz (microvolt squared per frequency). This is a common unit for spectral power density, and how relative power measures are displayed.

  Day 1 through Day 29 of Period 1 and Day 1 (study day 44) and Day 29 (study day 72) of Period 2

• Changes in Predose CT1812 Plasma Concentrations.

  For the measurements of pre-dose and post-dose plasma concentrations of CT1812, samples were collected 1± 0.25 hour predose. Single concentrations of CT1812 at selected predose and post-dose time points were reported.

  Baseline through Day 84: Pre and Post- Dose on Days 1, 29 AND Pre Dose Days 8, 15, 22.

Study Arms (2)

Active Treatment- CT1812

EXPERIMENTAL

Active Treatment- CT1812 at a dose of 300mg

Drug: CT1812; Other: Placebo

Control - Placebo

PLACEBO COMPARATOR

Drug: Placebo Non-active study drug

Drug: CT1812; Other: Placebo

Interventions

CT1812 DRUG

Active Treatment- CT1812 at a dose of 300mg

Active Treatment- CT1812; Control - Placebo

Placebo OTHER

Placebo Comparator

Active Treatment- CT1812; Control - 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:

• Women of non-childbearing potential and men, aged 50 to 85 years, inclusive, with a diagnosis of mild to moderate Alzheimer's disease according to the 2018 NIA-AA criteria and at least a 6-month history of decline in cognitive function documented in the medical record.
• i) Non-childbearing potential for women is defined as postmenopausal (last menses greater than 24 months) or undergone a documented bilateral tubal ligation or hysterectomy. If last menses less than 24 months, a serum follicle stimulating hormone (FSH) value confirming post-menopausal status may be used.
• ii) Male participants who are sexually active with a woman of child-bearing potential must agree to use condoms during the study and for 3 months after last dose. Female partners should also consider using an acceptable means of birth control, though it is not mandatory. 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.
• Formal education of 8 or more years.
• Participants must have a caregiver/study partner who in the opinion of the site's Principal Investigator, has contact with the study participant for a sufficient number of hours per week to provide informative responses on the protocol assessments, oversee the administration of study drug, and is willing and able to participate in all study site visits and some study assessments. The caregiver/ study partner must provide written informed consent to participate in the study.
• Participants living at home or in the community (assisted living acceptable).
• Participants must have no known history of difficulty swallowing capsules.
• Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening.
• Must consent to apolipoprotein E (APOE) genotyping.
• Participants shall be generally healthy with mobility (ambulatory or ambulatory-aided, ie, walker or cane), vision and hearing (hearing aid permissible) sufficient for compliance with testing procedures.
• Must be able to complete all screening evaluations.
• Hospitalization (except for planned procedures) or change of chronic concomitant medication within 1 month prior to screening.
• Participants living in a continuous care nursing facility.
• Contraindications to the MRI examination for any reason.
• Screening MRI (or historical MRI, if applicable) 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 (eg, abscess or brain tumor such as meningioma).
• Clinical or laboratory findings consistent with:
• Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc).

Sponsors & Collaborators

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

Study Sites (1)

Brain Research Center

Amsterdam, Netherlands

Location

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

• Everard Vijverberg, MD

  Brain Research Center, Amsterdam

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-site, randomized, double-blind, placebo-controlled, 29-day, 2-period crossover Phase 2 study of 1 dose level of CT1812 (active) or placebo in adults with mild to moderate AD.

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 3, 2021
• Study Start: July 9, 2020
• Primary Completion: April 26, 2023
• Study Completion: April 26, 2023
• Last Updated: November 29, 2024
• Results First Posted: November 29, 2024

Record last verified: 2024-11

Locations

NL (1)