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Clinical Trial of CT1812 in Mild to Moderate Alzheimer's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Clinical Trial of CT1812 in Mild to Moderate Alzheimer's Disease

A Randomized, Double-Blind, Placebo-Controlled, Phase I Study of the Safety & Pharmacokinetics of Two Doses of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease

NCT02907567•Cognition Therapeutics

View on ClinicalTrials.gov

Summary

This is a multi-center, randomized, double-blind, placebo-controlled, parallel group study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease to evaluate the safety and tolerability of oral CT1812, administered for 28 days. This trial may include up to 8 qualified investigator sites in Australia.

Detailed Description

Screening procedures will occur up to 42 days. Eligible subjects will randomized at the clinic on Day 1 and receive the first dose of study drug. Dosing for 28 days thereafter off-site and a total of 5 clinic visits over the treatment period for safety and lab assessments. Then a 7 day post-treatment completion follow-up visit (Day 35) and End of Study for last safety assessments (Day 49).

Eligibility

Age

50 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Willing and able to provide written informed consent prior to initiation of any study-related procedures. For subjects unable to provide written consent, consent will be provided by the Person Responsible per local regulations.
•2. Men and women, 50-80 years in age inclusively with a diagnosis of mild to moderate Alzheimer's disease according to the 2011 NIA-AA. Women must be neither pregnant nor nursing, and are either surgically sterile, postmenopausal or premenopausal using an acceptable method of contraception.
•3. Previous decline in cognition for more than six months.
•4. Neuroimaging (MRI) obtained within the previous 6 months or during screening, consistent with the clinical diagnosis of Alzheimer's disease.
•5. MMSE 18-26 inclusive.
•6. No active depression and a Geriatric Depression Score (GDS) of \< 6.
•7. Modified Hachinski Ischemia score ≤ 4.
•8. Formal education of eight or more years.
•9. Living at home or in a community setting (assisted living) without continuous nursing care. Each subject must have a reliable caregiver who sees them at least 3 times weekly, can oversee the administration of study drug, and is willing and able to participate in all clinic visits and some study procedures. Responsible caregiver must provide written informed consent to participate.
•10. Concurrent use of acetylcholinesterase inhibitors or memantine must be stable for 90 days prior to screening and not expected to change.

Exclusion Criteria

•1. History of or screening brain MRI scan 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).
•2. Clinical or laboratory findings consistent with:
•1. Other primary degenerative dementia,
•2. Other neurodegenerative condition
•3. Seizure disorder
•4. Other infectious, metabolic or systemic diseases affecting the central nervous system
•3. A current DSM-V diagnosis of active major depression, schizophrenia or bipolar disorder.
•4. Clinically significant, advanced or unstable disease that may interfere with outcome measures, and which may bias the assessment of the clinical or mental status of the patient or put the patient at special risk

Locations (4)

Dr. Phillip Morris

Southport, Queensland, Australia

Austin Health

Ivanhoe, Victoria, Australia

Epworth Hospital

Melbourne, Victoria, Australia

The Royal Melbourne Hospital Hospital

Parkville, Victoria, Australia

Key Dates

Start Date

September 1, 2016

Primary Completion Date

August 24, 2017

Completion Date

September 1, 2017

Last Updated

July 26, 2018

Enrollment

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

CT1812

DRUG

Placebo

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 26, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Trial of CT1812 in Mild to Moderate Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

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