Alzheimer Disease
Conditions
Keywords
Alzheimer's Disease
Brief summary
This is a multi-center, Phase 1b, randomized, double-blind, placebo-controlled parallel-group trial in adults with mild to moderate AD.
Detailed description
This is a multi-center, Phase 1b, randomized, double-blind, placebo-controlled parallel-group trial in adults with mild to moderate AD. The primary endpoint is the change from the baseline CSF Amyloid beta oligomer concentration after dosing with CT1812 versus placebo. The change from baseline will be measured through a number of exploratory endpoints as indicated below. For each subject, the baseline CSF oligomer concentration will be computed as the average of the measurements from hours -4, -3, -2 and -1 and 0.
Interventions
DRUGCT1812
Active Study Drug
DRUGPlacebo
Non-active study drug
Sponsors
Cognition Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind for study site and participants
Intervention model description
Phase 1b, randomized, double-blind, placebo-controlled parallel-group trial in adults with mild to moderate AD.
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Subjects may be included in the study only if they meet all of the following criteria: 1. Men, and women of non-childbearing potential, 50-85 years of age inclusively, with a diagnosis of mild to moderate Probable Alzheimer's Disease Dementia according to the 2011 NIA-AA criteria and at least a 6 month decline in cognitive function documented in the medical record. 1. a. 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 2. b. Male participants who are sexually active with a woman of childbearing potential must agree to use condoms during the trial 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. 2. Neuromaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer's disease and without findings of significant exclusionary abnormalities (see
Exclusion criteria
, number 3). 3. MMSE 18-26 inclusive. Subjects must, in the opinion of the investigator, be able to comply with study procedures and must understand the consent process. The investigator will use his or her clinical judgment in conjunction with the cognitive screening assessments to determine whether the subject meets these criteria in a manner that is consistent with local clinical practice and standards. Subjects with borderline low MMSE at screening may undergo repeat MMSE administration if extenuating circumstances were present at original assessment. 4. A positive amyloid scan (florbetaben F18, florbetapir F18, or flutametamol F18) at screening or within prior 12 months, as read by the certified, site-designated PET scan reader. 5. Must consent to apolipoprotein E (ApoE) genotyping. 6. Subjects must have a caregiver or study partner who can participate in all clinic visits. 7. Patients living at home or in the community (assisted living acceptable). 8. Able to swallow CT1812 capsules. 9. Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening. 10. Subjects must be capable of providing either written informed consent to the study procedures and for use of protected health information \[Health Insurance Portability and Accountability Act (HIPAA) Authorization, if applicable\]. Written informed consent also shall be obtained from the responsible caregiver or study partner. All consent processes must be undertaken in the presence of a witness and prior to any study procedures. 11. Subjects shall be 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. 12. Must be able to complete all screening evaluations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measuring the displacement of Amyloid beta oligomers into cerebrospinal fluid (CSF) | 48 hours | evidence of oligomer displacement as demonstrated by a clear rise in CSF oligomer concentration relative to baseline and placebo |
Countries
United States
Outcome results
None listed