COG0107

CompletedPhase 1

Study to Assess the Pharmacokinetics of CT1812 in Older Healthy Volunteers

A Phase 1 Study to Assess the Pharmacokinetics of Different Multiple Dose Regimens of CT1812 in Older Healthy Volunteers

Lead sponsor

Cognition Therapeutics

Asset

CT1812

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 50-80

Primary endpoints

•Pharmacokinetics (PK) in plasma•Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF)•Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF)- CSF/plasma ratio

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCOG0107

NCT IDNCT05248672

Timeline

Milestones

Study start2022-02-15actual

Study first posted2022-02-21actual

Primary completion2022-06-01actual

Study completion2022-06-01actual

Last update posted2023-04-12actual

Assets

Drug assets

CT1812

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age80 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Men and Women 50-80 years of age, inclusively

•In good health as determined by the Investigator with no clinically significant abnormalities

•Weight between 50.0 and 100.0 kg, inclusive at Screening

•No suicidal ideation

•No active depression

•Living independently at home or in a community setting

•Able to swallow CT1812 capsule or capsules

•Non-smoker with no history of using tobacco or any nicotine-containing products

•Subjects with negative serology for HIV, Hepatitis B, and C

•Negative results for drugs of abuse, cotinine, and alcohol

•Negative test results for COVID-19

•Willing to comply with Clinical Pharmacology Unit's COVID-19 policies

Exclusion criteria

•Any chronic medical condition which, in the opinion of the investigator, might pose a safety risk to the subject or interfere with study interpretation

•Subject with active or recent infection requiring antibiotic therapy

•Medical history of vasculitis or any autoimmune disease

•Any recent hospitalization

•Subjects living in a continuous care nursing facility

•Any contraindication to a lumbar puncture

•Subjects with self-reported history of major depression

•History of diabetes

•Intake of drugs or substances potentially involved in clinically significant induction or inhibition of CYP3A4 or P-gp mediated drug interactions with CT1812

•Intake of investigational drug prior to study drug administration on Day 1

•Participation in an investigational device study prior to study drug administration on Day 1

•Grapefruit, grapefruit juice, and Seville oranges/juice must be avoided within 14 days prior to dosing and throughout the course of the study

•Suspected or known drug or alcohol abuse,

•Excessive consumption of coffee, tea, cola, or other caffeinated beverages

•Loss or donation of blood; nation of bone marrow or peripheral stem cells; or donation of plasma

•Venous access considered inadequate; history or evidence of adverse symptoms associated with phlebotomy or blood donation

•Suspected or known allergy to any component of the study treatments

•Employee or family member of the Investigator, study site personnel, or Sponsor

•A subject with any condition that, in the opinion of the Investigator, makes the subject unsuitable for study participation will be excluded

Endpoints (22)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Fluid / digital biomarkers

Safety / tolerability / PK