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

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.

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Mild to Moderate Alzheimer's Disease
• Intervention / Treatment: Drug: Placebo; Drug: CT1812

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.

• Study Type: Interventional
• Enrollment (Actual): 378
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Executive Assistant; Phone Number: 412-481-2210; Email: clinicaltrials@cogrx.com

Study Locations

• Australia
  • Victoria
    • Ivanhoe, Victoria, Australia, 3079
      • St Vincent's Hospital Sydney
    • Melbourne, Victoria, Australia, 3004
      • Alfred Health
    • Parkville, Victoria, Australia, 3050
      • Melbourne Health
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Australian Alzheimer's Research Foundation
• Czechia
  • Brno, Czechia, 628 00
    • Neuro Health Centrum ltd
  • Hradec Králové, Czechia, 503 41
    • NeuropsychiatrieHK S.R.O
  • Plzen, Czechia, 30100
    • A-SHINE s.r.o
  • Prague, Czechia, 160 00
    • Forbeli S.R.O
  • Praha, Czechia, 100 00
    • Clintrial S.R.O
  • Praha 6, Czechia, 16 000
    • Neuropsychiatrie s.r.o.
  • Praha 8, Czechia, 18600
    • INEP
  • Rychnov Nad Kněžnou, Czechia, 51601
    • Vestra Clinics
• Netherlands
  • Amsterdam, Netherlands, 1081 GN
    • Brain Research Center Amsterdam
  • Den Bosch, Netherlands, 5223 LA
    • Brain Research Den Bosch
  • Zwolle, Netherlands, 8025 AZ
    • Brain Research Center Zwolle
• Spain
  • Barcelona, Spain, 08028
    • Fundación ACE
  • El Palmar, Spain, 30120
    • Hospital Clínico Universitario Virgen de la Arrixaca
  • Salamanca, Spain, 37005
    • Centro de Salud San Juan
  • Sevilla, Spain, 41009
    • Hospital Victoria EUGENIA. Unidad de Neurociencias.
  • Zaragoza, Spain, 5000
    • Fundacion Neuropolis - Hospital Viamed Montecanal
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • 21st Century Neurology/ Xenoscience Inc.
    • Scottsdale, Arizona, United States, 85258
      • Imaging Endpoints
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Ki Health Partners, LLC dba New England Institute for Clinical Research
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research Institute
    • Lady Lake, Florida, United States, 32159
      • Charter Research
    • Maitland, Florida, United States, 32751
      • ClinCloud, LLC
    • Miami, Florida, United States, 33155
      • Allied Biomedical Research Institute
    • The Villages, Florida, United States, 32162
      • Compass Research LLC- Bioclinica Research
    • Viera, Florida, United States, 32940
      • ClinCloud
  • North Carolina
    • Charlotte, North Carolina, United States, 28270
      • Alzheimer's Memory Center
  • Ohio
    • Columbus, Ohio, United States, 43221-3502
      • The Ohio State University - Wexner
    • North Canton, Ohio, United States, 44720
      • Neuro Behavirol Clinical Research C

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Treatment- CT1812 100 mg; CT1812 at a dose of 100 n=48 group	Drug: CT1812; Active Study Drug; Other Names: Study Drug
Active Comparator: Active Treatment- CT1812 300 mg; CT1812 at a dose of 300mg, n=48 group	Drug: CT1812; Active Study Drug; Other Names: Study Drug
Placebo Comparator: Placebo Comparator - Placebo; Placebo, n=48 group	Drug: Placebo; Non-active study drug; Other Names: Matching Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cognition Therapeutics
• Collaborators: National Institute on Aging (NIA)
• Investigators: Study Director: Anthony Caggiano, MD, Cognition Therapeutics

Publications and helpful links

Helpful Links

• Title: " Ready to shine a new light on Alzheimer's disease?"

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Estimated): July 26, 2024
• Study Completion (Estimated): July 26, 2024

Study Registration Dates

• First Submitted: April 10, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 25, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Alzheimer's Disease
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: COG0201; R01AG058660 (U.S. NIH Grant/Contract); 2022-002326-27 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No