A Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease.
- Conditions
- Mild to Moderate Alzheimer's Disease
- Interventions
- Drug: Placebo
- 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).
This Phase 2 study is designed to evaluate the safety of two doses of CT1812 administered once daily for 6 months in adults aged 50 to 85 who have been diagnosed with mild to moderate Alzheimer's disease (the targeted clinical indication for CT1812). Randomized participants will receive 100 mg of CT1812, 300 mg of CT1812, or placebo once daily for 182 days. Exploratory endpoints that evaluate the effect of CT1812 on biomarkers are also included.
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
๐บ๐ธScottsdale, Arizona, United States
St Vincent's Hospital Sydney
๐ฆ๐บIvanhoe, Victoria, Australia
Alfred Health
๐ฆ๐บMelbourne, Victoria, Australia
Charter Research
๐บ๐ธLady Lake, Florida, United States
Neuropsychiatrie s.r.o.
๐จ๐ฟPraha 6, Czechia
Neuro Health Centrum ltd
๐จ๐ฟBrno, Czechia
Clintrial S.R.O
๐จ๐ฟPraha, Czechia
Brain Research Den Bosch
๐ณ๐ฑDen Bosch, Netherlands
JEM Research Institute
๐บ๐ธAtlantis, Florida, United States
NeuropsychiatrieHK S.R.O
๐จ๐ฟHradec Krรกlovรฉ, Czechia
Forbeli S.R.O
๐จ๐ฟPrague, Czechia
ClinCloud
๐บ๐ธViera, Florida, United States
ClinCloud, LLC
๐บ๐ธMaitland, Florida, United States
A-Shine S.R.O
๐จ๐ฟPlzen, Czechia
Centro de Salud San Juan
๐ช๐ธSalamanca, Spain
Brain Research Center Zwolle
๐ณ๐ฑZwolle, Netherlands
Fundaciรณn ACE
๐ช๐ธBarcelona, Spain
Fundaciรณn Neuropolis - Hospital Viamed Montecanal
๐ช๐ธZaragoza, Spain
INEP
๐จ๐ฟPraha 8, Czechia
Australian Alzheimer's Research Foundation
๐ฆ๐บNedlands, Western Australia, Australia
21st Century Neurology/ Xenoscience Inc.
๐บ๐ธPhoenix, Arizona, United States
Neuro Behavirol Clinical Research C
๐บ๐ธNorth Canton, Ohio, United States
Ki Health Partners, LLC dba New England Institute for Clinical Research
๐บ๐ธStamford, Connecticut, United States
Allied Biomedical Research Institute
๐บ๐ธMiami, Florida, United States
Alzheimer's Memory Center
๐บ๐ธCharlotte, North Carolina, United States
The Ohio State University - Wexner
๐บ๐ธColumbus, Ohio, United States
Melbourne Health
๐ฆ๐บParkville, Victoria, Australia
Brain Research Center Amsterdam
๐ณ๐ฑAmsterdam, Netherlands
Vestra Clinics
๐จ๐ฟRychnov Nad Knฤลพnou, Czechia
Hospital Clinico Universitario Virgen De La Arrixaca
๐ช๐ธEl Palmar, Spain
Hospital Victoria EUGENIA. Unidad de Neurociencias.
๐ช๐ธSevilla, Spain
Compass Research LLC- Bioclinica Research
๐บ๐ธThe Villages, Florida, United States