A Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease.
- Conditions
- Interventions
- Registration Number
- NCT03507790
- Lead Sponsor
- Cognition Therapeutics
- Brief Summary
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).
- Detailed Description
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).
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Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
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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.
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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
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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.).
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MMSE 18-26 inclusive.
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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..
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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.).
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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.
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Clinically significant, advanced or unstable disease that may interfere with outcome evaluations.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Treatment- CT1812 100 mg CT1812 CT1812 at a dose of 100 n=48 group Active Treatment- CT1812 300 mg CT1812 CT1812 at a dose of 300mg, n=48 group Placebo Comparator - Placebo Placebo Placebo, n=48 group
- Primary Outcome Measures
Name Time Method Number of study participants with treatment related adverse events and serious adverse events 210 Days Adverse events will be collected starting at Day 1 through Day 210 to evaluate safety.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
Imaging Endpoints
🇺🇸Scottsdale, Arizona, United States
St Vincent's Hospital Sydney
🇦🇺Ivanhoe, Victoria, Australia
Alfred Health
🇦🇺Melbourne, Victoria, Australia
Charter Research
🇺🇸Lady Lake, Florida, United States
Neuropsychiatrie s.r.o.
🇨🇿Praha 6, Czechia
Neuro Health Centrum ltd
🇨🇿Brno, Czechia
Clintrial S.R.O
🇨🇿Praha, Czechia
Brain Research Den Bosch
🇳🇱Den Bosch, Netherlands
JEM Research Institute
🇺🇸Atlantis, Florida, United States
NeuropsychiatrieHK S.R.O
🇨🇿Hradec Králové, Czechia
Forbeli S.R.O
🇨🇿Prague, Czechia
ClinCloud
🇺🇸Viera, Florida, United States
ClinCloud, LLC
🇺🇸Maitland, Florida, United States
A-Shine S.R.O
🇨🇿Plzen, Czechia
Centro de Salud San Juan
🇪🇸Salamanca, Spain
Brain Research Center Zwolle
🇳🇱Zwolle, Netherlands
Fundación ACE
🇪🇸Barcelona, Spain
Fundación Neuropolis - Hospital Viamed Montecanal
🇪🇸Zaragoza, Spain
INEP
🇨🇿Praha 8, Czechia
Australian Alzheimer's Research Foundation
🇦🇺Nedlands, Western Australia, Australia
21st Century Neurology/ Xenoscience Inc.
🇺🇸Phoenix, Arizona, United States
Neuro Behavirol Clinical Research C
🇺🇸North Canton, Ohio, United States
Ki Health Partners, LLC dba New England Institute for Clinical Research
🇺🇸Stamford, Connecticut, United States
Allied Biomedical Research Institute
🇺🇸Miami, Florida, United States
Alzheimer's Memory Center
🇺🇸Charlotte, North Carolina, United States
The Ohio State University - Wexner
🇺🇸Columbus, Ohio, United States
Melbourne Health
🇦🇺Parkville, Victoria, Australia
Brain Research Center Amsterdam
🇳🇱Amsterdam, Netherlands
Vestra Clinics
🇨🇿Rychnov Nad Kněžnou, Czechia
Hospital Clinico Universitario Virgen De La Arrixaca
🇪🇸El Palmar, Spain
Hospital Victoria EUGENIA. Unidad de Neurociencias.
🇪🇸Sevilla, Spain
Compass Research LLC- Bioclinica Research
🇺🇸The Villages, Florida, United States