A Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease.

Completed · Phase 2 · Has a placebo group

Conditions studied: Mild to Moderate Alzheimer's Disease

In brief

This is a multi-center, randomized, double-blind, placebo-controlled, parallel group 36 week multicenter Phase 2 study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease (AD).

Key facts

Study ID

NCT03507790

Run by

Cognition Therapeutics

People needed

153

Starts

2018-10-10

Expected to finish

2024-05-29

Last updated by the study team

2025-08-11

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• i) Non-childbearing potential for women is defined as postmenopausal (last natural menses greater than 24 months) or undergone a documented bilateral tubal ligation or hysterectomy. If last natural menses less than 24 months, a serum FSH value confirming post-menopausal status can be employed.
• ii) 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.
• Diagnostic confirmation by amyloid PET with florbetaben or another approved amyloid PET ligand. Previous amyloid imaging study with a positive result will be accepted. If none is available, then amyloid PET will be conducted during screening. Diagnostic confirmation by a CSF sample collected at the screening visit lumbar puncture in place of amyloid PET will also be acceptable
• Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer's disease and without findings of significant exclusionary abnormalities (see exclusion criteria, number 4). An historical MRI, up to 1 year prior to screening, may be used as long as there is no history of intervening neurologic disease or clinical events (such as a stroke, head trauma etc.) and the subject is without clinical symptoms or signs suggestive of such intervening events.).
• MMSE 18-26 inclusive.

You may not qualify if…

• 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 (e.g. abscess or brain tumor such as meningioma). If a small incidental meningioma is observed, the medical monitor may be contacted to discuss eligibility..
• 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.).
• Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.).
• Seizure disorder.
• Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, other laboratory values etc.).
• A current DSM-V diagnosis of active major depression, schizophrenia or bipolar disorder. Subjects with depressive symptoms successfully managed by a stable dose of an antidepressant are allowed entry.
• Clinically significant, advanced or unstable disease that may interfere with outcome evaluations.

Where it is running

• 21st Century Neurology/ Xenoscience Inc. — Phoenix, Arizona, United States
• Imaging Endpoints — Scottsdale, Arizona, United States
• Ki Health Partners, LLC dba New England Institute for Clinical Research — Stamford, Connecticut, United States
• JEM Research Institute — Atlantis, Florida, United States
• Charter Research — Lady Lake, Florida, United States
• ClinCloud, LLC — Maitland, Florida, United States
• Allied Biomedical Research Institute — Miami, Florida, United States
• Compass Research LLC- Bioclinica Research — The Villages, Florida, United States
• ClinCloud — Viera, Florida, United States
• Alzheimer's Memory Center — Charlotte, North Carolina, United States
• The Ohio State University - Wexner — Columbus, Ohio, United States
• Neuro Behavirol Clinical Research C — North Canton, Ohio, United States
• St Vincent's Hospital Sydney — Ivanhoe, Victoria, Australia
• Alfred Health — Melbourne, Victoria, Australia
• Melbourne Health — Parkville, Victoria, Australia
• Australian Alzheimer's Research Foundation — Nedlands, Western Australia, Australia
• Neuro Health Centrum ltd — Brno, Czechia
• NeuropsychiatrieHK S.R.O — Hradec Králové, Czechia
• A-Shine S.R.O — Pilsen, Czechia
• Clintrial S.R.O — Prague, Czechia
• Neuropsychiatrie s.r.o. — Prague, Czechia
• Forbeli S.R.O — Prague, Czechia
• INEP — Prague, Czechia
• Vestra Clinics — Rychnov nad Kněžnou, Czechia
• Brain Research Den Bosch — 's-Hertogenbosch, Netherlands

Full record on ClinicalTrials.gov

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