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

Mild to Moderate Alzheimer's Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03507790
• Other study ID #: COG0201
• Secondary ID: R01AG0586602022-
• Status: Completed
• Phase: Phase 2
• Start date: October 10, 2018
• Est. completion date: May 29, 2024

Study information

• Verified date: June 2024
• Source: Cognition Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: May 29, 2024
• Est. primary completion date: May 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Mild to Moderate Alzheimer's Disease

Intervention

Drug:
• CT1812
Active Study Drug
• Placebo
Non-active study drug

Locations

Country	Name	City	State
Australia	St Vincent's Hospital Sydney	Ivanhoe	Victoria
Australia	Alfred Health	Melbourne	Victoria
Australia	Australian Alzheimer's Research Foundation	Nedlands	Western Australia
Australia	Melbourne Health	Parkville	Victoria
Czechia	Neuro Health Centrum ltd	Brno
Czechia	NeuropsychiatrieHK S.R.O	Hradec Králové
Czechia	A-Shine S.R.O	Plzen
Czechia	Forbeli S.R.O	Prague
Czechia	Clintrial S.R.O	Praha
Czechia	Neuropsychiatrie s.r.o.	Praha 6
Czechia	INEP	Praha 8
Czechia	Vestra Clinics	Rychnov Nad Knežnou
Netherlands	Brain Research Center Amsterdam	Amsterdam
Netherlands	Brain Research Den Bosch	Den Bosch
Netherlands	Brain Research Center Zwolle	Zwolle
Spain	Fundación ACE	Barcelona
Spain	Hospital Clinico Universitario Virgen De La Arrixaca	El Palmar
Spain	Centro de Salud San Juan	Salamanca
Spain	Hospital Victoria EUGENIA. Unidad de Neurociencias.	Sevilla
Spain	Fundación Neuropolis - Hospital Viamed Montecanal	Zaragoza
United States	JEM Research Institute	Atlantis	Florida
United States	Alzheimer's Memory Center	Charlotte	North Carolina
United States	The Ohio State University - Wexner	Columbus	Ohio
United States	Charter Research	Lady Lake	Florida
United States	ClinCloud, LLC	Maitland	Florida
United States	Allied Biomedical Research Institute	Miami	Florida
United States	Neuro Behavirol Clinical Research C	North Canton	Ohio
United States	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	Compass Research LLC- Bioclinica Research	The Villages	Florida
United States	ClinCloud	Viera	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Cognition Therapeutics	National Institute on Aging (NIA)

Countries where clinical trial is conducted

United States,  Australia,  Czechia,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of study participants with treatment related adverse events and serious adverse events	Adverse events will be collected starting at Day 1 through Day 210 to evaluate safety.	210 Days

External Links

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