Alzheimer DiseasePhase 1COG0107NCT05248672
Study to Assess the Pharmacokinetics of CT1812 in Older Healthy Volunteers
A Phase 1 study testing CT1812 in people with Alzheimer Disease, run by Cognition Therapeutics at 1 site in United States.
Trial summary
This an open label study to assess the pharmacokinetics of CT1812 in normal healthy volunteers. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- CT1812
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2022to 1 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Assess the Pharmacokinetics of Different Multiple Dose Regimens of CT1812 in Older Healthy Volunteers
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
- Alzheimer Disease
- Being tested
- CT1812
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT1812Drug
Study Drug
| Study group | Role | What they receive |
|---|---|---|
| 150 mg QD | Experimental | CT1812 150 mg QD Receives: Drug: CT1812 |
| 150 mg BID | Experimental | CT1812 150 mg BID Receives: Drug: CT1812 |
| 300 mg QD | Experimental | CT1812 300 mg QD Receives: Drug: CT1812 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) in plasma
Cmax: Maximum observed plasma concentration occurring at Tmax
Measured: Day 13 and 15.
Pharmacokinetics (PK) in plasma
Tmax: The first time to maximum observed concentration sampled during a dosing interval.
Measured: 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).
Measured: 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.
Measured: Day 13 and 15.
Pharmacokinetics (PK) in plasma
AUC 0-24h: AUC from time 0 to 24 hours post-dose.
Measured: 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.
Measured: 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.
Measured: Day 13 and 15.
Pharmacokinetics (PK) in plasma
AUC_%Extrap: Percent of AUC0-inf contributed by extrapolation beyond AUC0-last.
Measured: Day 13 and 15.
Pharmacokinetics (PK) in plasma
λz : Terminal elimination phase rate constant.
Measured: Day 13 and 15.
Pharmacokinetics (PK) in plasma
t½: Terminal phase half-life.
Measured: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Cmax - Maximum observed plasma concentration occurring at Tmax.
Measured: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Tmax -The first time to maximum observed concentration sampled during a dosing interval.
Measured: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Cavg,ss - Average plasma concentration at steady-state interval.
Measured: 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).
Measured: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Fluctuation (%) - Fluctuation (%) between maximum and minimum concentrations over the steady-state dosing interval.
Measured: 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) .
Measured: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
λz- Terminal elimination phase rate constant
Measured: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
t½ - Terminal phase half-life
Measured: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
AUCcum- Accumulation ratio in AUC, calculated as AUC0-tau,ss/AUC0-tau,D1
Measured: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Ctau,cum- Accumulation ratio in Ctau, calculated as Ctau,ss/Ctau,D1
Measured: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Cmax,cum - Accumulation ratio in Cmax, calculated as Cmax,ss/Cmax,D1
Measured: 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
Measured: Day 13 and 15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start15 Feb 2022
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open Label Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cognition Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony Caggiano, MD, Study director, Cognition Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248672
- Sponsor's protocol ID
- COG0107
- Acronym
- COG0107
- Status last verified
- Apr 2023
- First submitted
- 10 Feb 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess the Pharmacokinetics of Different Multiple Dose Regimens of CT1812 in Older Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05248672
- Acronym / sponsor ID
- COG0107 / COG0107
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Cognition TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This an open label study to assess the pharmacokinetics of CT1812 in normal healthy volunteers.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Open Label Study
| Arm | Type | Receives |
|---|---|---|
| 150 mg QD | Experimental | Drug: CT1812CT1812 150 mg QD |
| 150 mg BID | Experimental | Drug: CT1812CT1812 150 mg BID |
| 300 mg QD | Experimental | Drug: CT1812CT1812 300 mg QD |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT1812Study Drug | Drug | 150 mg BID, 150 mg QD, 300 mg QD |
Primary outcome
Pharmacokinetics (PK) in plasma
Time frame: Day 13 and 15.
Cmax: Maximum observed plasma concentration occurring at Tmax
Pharmacokinetics (PK) in plasma
Time frame: Day 13 and 15.
Tmax: The first time to maximum observed concentration sampled during a dosing interval.
Pharmacokinetics (PK) in plasma
Time frame: Day 13 and 15.
Ctau: Concentration at the end of the dosing interval (12 hr for BID group; 24 hr for QD group).
Pharmacokinetics (PK) in plasma
Time frame: Day 13 and 15.
AUC 0-12h: Area under the concentration-time curve (AUC) from time 0 to 12 hours post-dose.
Pharmacokinetics (PK) in plasma
Time frame: Day 13 and 15.
AUC 0-24h: AUC from time 0 to 24 hours post-dose.
Pharmacokinetics (PK) in plasma
Time frame: Day 13 and 15.
AUC 0-last: AUC from time 0 to the time of the last measurable concentration at 48 and 72 hours as applicable.
Pharmacokinetics (PK) in plasma
Time frame: Day 13 and 15.
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.
Pharmacokinetics (PK) in plasma
Time frame: Day 13 and 15.
AUC_%Extrap: Percent of AUC0-inf contributed by extrapolation beyond AUC0-last.
Pharmacokinetics (PK) in plasma
Time frame: Day 13 and 15.
λz : Terminal elimination phase rate constant.
Pharmacokinetics (PK) in plasma
Time frame: Day 13 and 15.
t½: Terminal phase half-life.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Time frame: Day 13 and 15.
Cmax - Maximum observed plasma concentration occurring at Tmax.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Time frame: Day 13 and 15.
Tmax -The first time to maximum observed concentration sampled during a dosing interval.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Time frame: Day 13 and 15.
Cavg,ss - Average plasma concentration at steady-state interval.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Time frame: Day 13 and 15.
Ctau-Concentration at the end of the dosing interval (12 hr for BID group; 24 hr for QD group).
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Time frame: Day 13 and 15.
Fluctuation (%) - Fluctuation (%) between maximum and minimum concentrations over the steady-state dosing interval.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Time frame: Day 13 and 15.
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) .
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Time frame: Day 13 and 15.
λz- Terminal elimination phase rate constant
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Time frame: Day 13 and 15.
t½ - Terminal phase half-life
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Time frame: Day 13 and 15.
AUCcum- Accumulation ratio in AUC, calculated as AUC0-tau,ss/AUC0-tau,D1
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Time frame: Day 13 and 15.
Ctau,cum- Accumulation ratio in Ctau, calculated as Ctau,ss/Ctau,D1
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Time frame: Day 13 and 15.
Cmax,cum - Accumulation ratio in Cmax, calculated as Cmax,ss/Cmax,D1
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF)- CSF/plasma ratio
Time frame: Day 13 and 15.
CSF/plasma ratio - Pre-dose on Day 13 and 3h (±15 min) post-dose on Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Caggiano, MD study director
Cognition Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CT1812 in people with Alzheimer Disease, run by Cognition Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK) in plasma (time frame: Day 13 and 15.). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.