Clinical trial NCT03507790: A Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease.
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mild to Moderate Alzheimer's Disease
Keywords: Alzheimer's Disease
Lead sponsor: Cognition Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-04-25
Enrollment: 153
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multi-center Phase 2, randomized, double-blind, placebo-controlled, parallel-group study.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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
3. 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.).
4. MMSE 18-26 inclusive.

Exclusion Criteria:

1. 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..
2. Clinical or laboratory findings consistent with:

   1. Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
   2. Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.).
   3. Seizure disorder.
   4. Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, other laboratory values etc.).
3. 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.
4. Clinically significant, advanced or unstable disease that may interfere with outcome evaluations.

Primary outcomes:
measure: Number of study participants with treatment related adverse events and serious adverse events
timeFrame: 210 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: 21st Century Neurology/ Xenoscience Inc.
state: Arizona
city: Scottsdale
country: United States
facility: Imaging Endpoints
state: Arizona
city: Stamford
country: United States
facility: Ki Health Partners, LLC dba New England Institute for Clinical Research
state: Connecticut
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Lady Lake
country: United States
facility: Charter Research
state: Florida
city: Maitland
country: United States
facility: ClinCloud, LLC
state: Florida
city: Miami
country: United States
facility: Allied Biomedical Research Institute
state: Florida
city: The Villages
country: United States
facility: Compass Research LLC- Bioclinica Research
state: Florida
city: Viera
country: United States
facility: ClinCloud
state: Florida
city: Charlotte
country: United States
facility: Alzheimer's Memory Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University - Wexner
state: Ohio
city: North Canton
country: United States
facility: Neuro Behavirol Clinical Research C
state: Ohio
city: Ivanhoe
country: Australia
facility: St Vincent's Hospital Sydney
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Health
state: Victoria
city: Parkville
country: Australia
facility: Melbourne Health
state: Victoria
city: Nedlands
country: Australia
facility: Australian Alzheimer's Research Foundation
state: Western Australia
city: Brno
country: Czechia
facility: Neuro Health Centrum ltd
city: Hradec Králové
country: Czechia
facility: NeuropsychiatrieHK S.R.O
city: Plzen
country: Czechia
facility: A-Shine S.R.O
city: Prague
country: Czechia
facility: Forbeli S.R.O
city: Praha 6
country: Czechia
facility: Neuropsychiatrie s.r.o.
city: Praha 8
country: Czechia
facility: INEP
city: Praha
country: Czechia
facility: Clintrial S.R.O
city: Rychnov Nad Kněžnou
country: Czechia
facility: Vestra Clinics
city: Amsterdam
country: Netherlands
facility: Brain Research Center Amsterdam
city: Den Bosch
country: Netherlands
facility: Brain Research Den Bosch
city: Zwolle
country: Netherlands
facility: Brain Research Center Zwolle
city: Barcelona
country: Spain
facility: Fundación ACE
city: El Palmar
country: Spain
facility: Hospital Clinico Universitario Virgen De La Arrixaca
city: Salamanca
country: Spain
facility: Centro de Salud San Juan
city: Sevilla
country: Spain
facility: Hospital Victoria EUGENIA. Unidad de Neurociencias.
city: Zaragoza
country: Spain
facility: Fundación Neuropolis - Hospital Viamed Montecanal
Study officials:
affiliation: Cognition Therapeutics
name: Anthony Caggiano, MD
role: STUDY_DIRECTOR
References: