CompletedNCT05248672COG0107Updated Apr 12, 2023

Study to Assess the Pharmacokinetics of CT1812 in Older Healthy Volunteers

A Phase 1 interventional study of CT1812 in Alzheimer Disease, sponsored by Cognition Therapeutics. Completed at 1 site in United States. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-12.

Sponsored by Cognition Therapeutics · Phase 1, Interventional, and Basic science

From the registry’s dates

Primary completion was Jun 2022, 4 years 4 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 35
Allocation: Randomized
Ages: 50 Years to 80 Years
Sex: All

Study summary

This an open label study to assess the pharmacokinetics of CT1812 in normal healthy volunteers.

Read the detailed description

Open label study to assess PK in 36 older healthy volunteers. Subjects will be screened 35 days prior dose to determine eligibility. On day -1 subjects will be admitted to the clinical research unit and on day 1 will be randomized to receive one of the following doses: 150 mg BID, 150 mg QD or 300 mg QD in the fed state. Subjects will be confined in the Clinical Research Unit where they will continue to receive study drug and complete safety assessments, PK and CSF draws, until day 16 when they will be discharged.

Conditions studied

Alzheimer Disease

Browse trials for

Alzheimer Disease 3,675

In context

Alzheimer Disease

3,675 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.

This study's enrollment of 35 is below the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Cognition Therapeutics is the lead sponsor of 13 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 50 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 35 participants (actual)

Study arms

Experimental
150 mg QD
CT1812 150 mg QD
Drug: CT1812
Experimental
150 mg BID
CT1812 150 mg BID
Drug: CT1812
Experimental
300 mg QD
CT1812 300 mg QD
Drug: CT1812

Interventions

DrugCT1812
Study Drug

What researchers measure

Primary outcomes

Pharmacokinetics (PK) in plasma
Cmax: Maximum observed plasma concentration occurring at Tmax
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in plasma
Tmax: The first time to maximum observed concentration sampled during a dosing interval.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in plasma
Ctau: Concentration at the end of the dosing interval (12 hr for BID group; 24 hr for QD group).
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in plasma
AUC 0-12h: Area under the concentration-time curve (AUC) from time 0 to 12 hours post-dose.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in plasma
AUC 0-24h: AUC from time 0 to 24 hours post-dose.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in plasma
AUC 0-last: AUC from time 0 to the time of the last measurable concentration at 48 and 72 hours as applicable.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in plasma
AUC 0-inf: Area under the concentration-time curve (AUC) from time 0 extrapolated to infinity, calculated using the observed value of the last non-zero concentration.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in plasma
AUC_%Extrap: Percent of AUC0-inf contributed by extrapolation beyond AUC0-last.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in plasma
λz : Terminal elimination phase rate constant.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in plasma
t½: Terminal phase half-life.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Cmax - Maximum observed plasma concentration occurring at Tmax.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Tmax -The first time to maximum observed concentration sampled during a dosing interval.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Cavg,ss - Average plasma concentration at steady-state interval.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Ctau-Concentration at the end of the dosing interval (12 hr for BID group; 24 hr for QD group).
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Fluctuation (%) - Fluctuation (%) between maximum and minimum concentrations over the steady-state dosing interval.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
AUC-0-tau - Area under the concentration-time curve from time 0 to the end of the dosing interval (0-12 for the BID group; 0 - 24 for the QD groups) .
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
λz- Terminal elimination phase rate constant
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
t½ - Terminal phase half-life
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
AUCcum- Accumulation ratio in AUC, calculated as AUC0-tau,ss/AUC0-tau,D1
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Ctau,cum- Accumulation ratio in Ctau, calculated as Ctau,ss/Ctau,D1
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Cmax,cum - Accumulation ratio in Cmax, calculated as Cmax,ss/Cmax,D1
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF)- CSF/plasma ratio
CSF/plasma ratio - Pre-dose on Day 13 and 3h (±15 min) post-dose on Day 15
Time frame: Day 13 and 15.

Study locations

1 site

Accel Clinical Research
DeLand, Florida 32720, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05248672
Lead sponsor: Cognition Therapeutics
Responsible party: Sponsor
First posted: Feb 21, 2022
Start date: Feb 15, 2022
Primary completion: Jun 1, 2022
Completion: Jun 1, 2022
Last update: Apr 12, 2023

Study contacts

Anthony Caggiano, MD

study director · Cognition Therapeutics

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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