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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-09-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active Treatment-Low

6 subjects randomized to 280 mg (Low) CT1812

Group Type ACTIVE_COMPARATOR

CT1812

Intervention Type DRUG

Active study drug

Active Treatment-High

6 subjects randomized to 560 mg (High) CT1812

Group Type ACTIVE_COMPARATOR

CT1812

Intervention Type DRUG

Active study drug

Placebo

4 subjects randomized to matching placebo of CT1812

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

non-active study drug

Interventions

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CT1812

Active study drug

Intervention Type DRUG

Placebo

non-active study drug

Intervention Type DRUG

Other Intervention Names

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Study Drug Matching placebo

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No