Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD).

• ClinicalTrials.gov Identifier: NCT05893537
• Recruitment Status: Recruiting
• First Posted: June 8, 2023
• Last Update Posted: March 13, 2024
• Sponsor: Cognition Therapeutics
• Information provided by (Responsible Party): Cognition Therapeutics

Tracking Information

• First Submitted Date: May 17, 2023
• First Posted Date: June 8, 2023
• Last Update Posted Date: March 13, 2024
• Actual Study Start Date: June 16, 2023
• Estimated Primary Completion Date: July 15, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 5, 2023)

Change from baseline in Geographic Atrophy (GA) lesion area over 104 weeks in the study eye. [ Time Frame: Baseline through Week 104 ]

Compare the mean rate of growth (slope) in GA lesion area in the study eye measured by fundus autofluorescence imaging (FAF).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 5, 2023)

• Safety and Tolerability of CT1812 [ Time Frame: Baseline through Week 104 ]
  Incidence and Severity of Adverse Events compared to placebo in participants with GA secondary to dry AMD.
• Plasma concentration of CT1812 [ Time Frame: Baseline through Week 104 ]
  Measure pre-dose plasma concentration of CT1812.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD).
• Official Title: A Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Phase 2 Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD).
• Brief Summary: This is a Phase 2, prospective, multicenter, randomized, double-masked, placebo-controlled 104-week study to assess the efficacy, safety, and tolerability of orally delivered CT1812 compared to placebo in participants with GA associated with dry AMD.

Detailed Description

This is a Phase 2, prospective, multicenter, randomized, double-masked, placebo-controlled 104-week study to assess the efficacy, safety, and tolerability of orally delivered CT1812 compared to placebo in participants with GA associated with dry AMD.

Participants ≥50 years old diagnosed with GA secondary to dry AMD and who meet all inclusion criteria and none of the exclusion criteria will be included in the study. The study will randomize up to 246 participants in a 1:1 manner (123 participants per treatment group) to receive a single daily dose of either CT1812 (200 mg) or placebo across approximately 40-50 sites.

Following a screening period of up to 28 days, the total expected duration of participant participation in the study will be 108 weeks (104-week treatment period followed by a 28-day [4-week] post treatment safety follow up period).

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Age-Related Macular Degeneration

Intervention

• Drug: Active Comparator CT1812
  123 participants will receive a single daily dose of CT1812 (200 mg)
• Drug: Placebo Comparator
  123 participants will receive a single daily dose of placebo

Study Arms

• Active Comparator: CT1812 200 mg
  Drug: CT1812 Active Study Drug
  Intervention: Drug: Active Comparator CT1812
• Placebo Comparator: Placebo
  Placebo
  Intervention: Drug: Placebo Comparator

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 5, 2023): 246
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 15, 2027
• Estimated Primary Completion Date: July 15, 2027 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Age ≥50 years at time of informed consent.
2. BCVA of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
3. Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening.

EXCLUSION CRITERIA:

1. GA due to causes other than dry AMD.
2. Any history or current evidence of exudative ("wet") AMD.
3. Retinal disease other than dry AMD.
4. Any ophthalmologic condition that prevents adequate imaging of the retina as judged by the study site or central reading center.
5. Intraocular surgery (including intraocular lens implantation surgery) within 3 months prior to randomization.
6. Any ophthalmic condition that will or is likely to require surgery during the study period.
7. Hypersensitivity to fluorescein.
8. Suspected or known allergy to any components of the study treatments.
9. History of vitrectomy surgery, submacular surgery or any other surgical intervention for dry AMD.
10. History of glaucoma filtering surgery or corneal transplant in the study eye.
11. History of central serous retinopathy in either eye.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Diana Executive Assistant; 888-745-1050; clinicaltrials@cogrx.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05893537
• Other Study ID Numbers: COG2201
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Cognition Therapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: Cognition Therapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Anthony Caggiano; Cognition Therapeutics Inc.

• PRS Account: Cognition Therapeutics
• Verification Date: March 2024