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Clinical Trial of CT1812 in Mild to Moderate Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT02907567
Recruitment Status : Completed
First Posted : September 20, 2016
Last Update Posted : July 26, 2018
Information provided by (Responsible Party):
Cognition Therapeutics

Tracking Information
First Submitted Date  ICMJE September 5, 2016
First Posted Date  ICMJE September 20, 2016
Last Update Posted Date July 26, 2018
Actual Study Start Date  ICMJE September 2016
Actual Primary Completion Date August 24, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2016)
Incidence and review of Treatment Emergent Adverse Events [ Time Frame: Up to 30 days ]
Treatment Emergent Adverse Events will be assessed by reviewing: Physical Exams; monitoring of vital signs, ECGs, and clinical and laboratory assessments
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Clinical Trial of CT1812 in Mild to Moderate Alzheimer's Disease
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Phase I Study of the Safety & Pharmacokinetics of Two Doses of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease
Brief Summary This is a multi-center, randomized, double-blind, placebo-controlled, parallel group study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease to evaluate the safety and tolerability of oral CT1812, administered for 28 days. This trial may include up to 8 qualified investigator sites in Australia.
Detailed Description Screening procedures will occur up to 42 days. Eligible subjects will randomized at the clinic on Day 1 and receive the first dose of study drug. Dosing for 28 days thereafter off-site and a total of 5 clinic visits over the treatment period for safety and lab assessments. Then a 7 day post-treatment completion follow-up visit (Day 35) and End of Study for last safety assessments (Day 49).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: CT1812
    Active study drug
    Other Name: Study Drug
  • Drug: Placebo
    non-active study drug
    Other Name: Matching placebo
Study Arms  ICMJE
  • Active Comparator: Active Treatment-Low
    6 subjects randomized to 280 mg (Low) CT1812
    Intervention: Drug: CT1812
  • Active Comparator: Active Treatment-High
    6 subjects randomized to 560 mg (High) CT1812
    Intervention: Drug: CT1812
  • Placebo Comparator: Placebo
    4 subjects randomized to matching placebo of CT1812
    Intervention: Drug: Placebo
Publications * Izzo NJ, Yuede CM, LaBarbera KM, Limegrover CS, Rehak C, Yurko R, Waybright L, Look G, Rishton G, Safferstein H, Hamby ME, Williams C, Sadlek K, Edwards HM, Davis CS, Grundman M, Schneider LS, DeKosky ST, Chelsky D, Pike I, Henstridge C, Blennow K, Zetterberg H, LeVine H 3rd, Spires-Jones TL, Cirrito JR, Catalano SM. Preclinical and clinical biomarker studies of CT1812: A novel approach to Alzheimer's disease modification. Alzheimers Dement. 2021 Aug;17(8):1365-1382. doi: 10.1002/alz.12302. Epub 2021 Feb 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2018)
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2016)
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date August 24, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Willing and able to provide written informed consent prior to initiation of any study-related procedures. For subjects unable to provide written consent, consent will be provided by the Person Responsible per local regulations.
  2. Men and women, 50-80 years in age inclusively with a diagnosis of mild to moderate Alzheimer's disease according to the 2011 NIA-AA. Women must be neither pregnant nor nursing, and are either surgically sterile, postmenopausal or premenopausal using an acceptable method of contraception.
  3. Previous decline in cognition for more than six months.
  4. Neuroimaging (MRI) obtained within the previous 6 months or during screening, consistent with the clinical diagnosis of Alzheimer's disease.
  5. MMSE 18-26 inclusive.
  6. No active depression and a Geriatric Depression Score (GDS) of < 6.
  7. Modified Hachinski Ischemia score ≤ 4.
  8. Formal education of eight or more years.
  9. Living at home or in a community setting (assisted living) without continuous nursing care. Each subject must have a reliable caregiver who sees them at least 3 times weekly, can oversee the administration of study drug, and is willing and able to participate in all clinic visits and some study procedures. Responsible caregiver must provide written informed consent to participate.
  10. Concurrent use of acetylcholinesterase inhibitors or memantine must be stable for 90 days prior to screening and not expected to change.

Exclusion Criteria:

  1. History of or screening brain MRI scan 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).
  2. Clinical or laboratory findings consistent with:

    1. Other primary degenerative dementia,
    2. Other neurodegenerative condition
    3. Seizure disorder
    4. Other infectious, metabolic or systemic diseases affecting the central nervous system
  3. A current DSM-V diagnosis of active major depression, schizophrenia or bipolar disorder.
  4. Clinically significant, advanced or unstable disease that may interfere with outcome measures, and which may bias the assessment of the clinical or mental status of the patient or put the patient at special risk
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02907567
Other Study ID Numbers  ICMJE COG0102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Cognition Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cognition Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Woodward, MD Austin Health
PRS Account Cognition Therapeutics
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP