Study to Evaluate the Efficacy and Safety of Oral CT1812... | NCT05893537

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The trial was closed as part of a strategic business decision.

Expanded Access Info

Start Date

Jun 16, 2023Actual

Primary Completion Date

Mar 4, 2025Actual

Completion Date

Mar 28, 2025Actual

First Submitted Date

May 17, 2023

First Submission Date that Met QC Criteria

Jun 5, 2023

First Posted Date

Jun 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2025

Last Update Posted Date

Apr 16, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

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 60 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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CT1812 200 mg	Active Comparator	Drug: CT1812 Active Study Drug	Drug: Active Comparator CT1812
Placebo	Placebo Comparator	Placebo	Drug: Placebo Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Active Comparator CT1812	Drug	123 participants will receive a single daily dose of CT1812 (200 mg)	CT1812 200 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in Geographic Atrophy (GA) lesion area over 104 weeks in the study eye.	Compare the mean rate of growth (slope) in GA lesion area in the study eye measured by fundus autofluorescence imaging (FAF).	Baseline through Week 104

Secondary Outcomes

Measure	Description	Time Frame
Safety and Tolerability of CT1812	Incidence and Severity of Adverse Events compared to placebo in participants with GA secondary to dry AMD.	Baseline through Week 104
Plasma concentration of CT1812

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

EXCLUSION CRITERIA:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anthony Caggiano	Cognition Therapeutics Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Phoenix Retina Associates		Phoenix	Arizona	85050	United States
Retinal Consultants Medical Group

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41747884	Derived	Lizama BN, Reaver A, Look G, Caggiano AO, Hamby ME. Sigma-2 receptor modulators alter low-density lipoprotein receptor-mediated lipid uptake in retinal pigment epithelial cells. Exp Eye Res. 2026 Jun;267:110944. doi: 10.1016/j.exer.2026.110944. Epub 2026 Feb 24.

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases