NCT04735536 is a Phase 2 clinical trial of CT1812 in Alzheimer Disease, sponsored by Cognition Therapeutics.

Who is sponsoring NCT04735536?

NCT04735536 is sponsored by Cognition Therapeutics.

What drugs are being tested in NCT04735536?

Interventions in NCT04735536: CT1812, Placebo.

What condition does NCT04735536 study?

NCT04735536 studies Alzheimer Disease.

Is NCT04735536 still recruiting?

NCT04735536 is currently completed. Last updated 29 November 2024.

Are results published for NCT04735536?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-11-29 · How we verify

NCT04735536

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pilot Clinical Study of CT1812 in Mild to Moderate Alzheimer's Disease Using EEG

Completed Phase 2 Results posted Last updated 29 November 2024

What this trial tests

Phase 2 trial testing CT1812 in Alzheimer Disease in 16 participants. Completed in 26 April 2023.

Timeline

9 July 2020

Primary endpoint
26 April 2023

26 April 2023

Quick facts

Lead sponsor	Cognition Therapeutics
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	16
Start date	9 July 2020
Primary completion	26 April 2023
Estimated completion	26 April 2023
Sites	1 location across Netherlands

Drugs / interventions tested

CT1812 — full drug profile →
Placebo

Conditions studied

Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

Cognition Therapeutics — full company profile →

Who can join

Adults 50 to 85, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of TEAEs, Related TEAEs, SAEs, and Related SAEs Primary · Up to 126 days

Adverse events were captured from the start of study-related procedures at Visit 1 (including diagnostic assessments or signing of ICF) onward during the course of this study. Adverse events were coded using MedDRA Version 22.0

All TEAEs

Group	Value	95% CI
Placebo	6
CT1812	11

Mild TEAEs

Group	Value	95% CI
Placebo	4
CT1812	7

Moderate TEAEs

Group	Value	95% CI
Placebo	2
CT1812	4

Severe TEAEs

Group	Value	95% CI
Placebo	0
CT1812	0

Related TEAEs

Group	Value	95% CI
Placebo	3
CT1812	3

TEAEs Leading to Treatment Discontinuation

Group	Value	95% CI
Placebo	0
CT1812	0

SAEs

Group	Value	95% CI
Placebo	0
CT1812	0

Related SAEs

Group	Value	95% CI
Placebo	0
CT1812	0

Change in the Brain Activity Reflected by Changes of Spectral Power in Conventional Frequency Bands Measured by the Global Relative Theta (4-8 Hz) Power Obtained Through EEG Assessment. Primary · Day 1 through Day 29 of Period 1 and Day 1 (study day 44) and Day 29 (study day 72) of Period 2

Global relative theta power was quantified and summarized descriptively (observed values, change from the pre-treatment values) by treatment and time point using the Safety Population. The change from period baseline in global relative theta power within each period was analyzed using a linear mixed model with fixed effects for treatment group (CT1812 or placebo), sequence, and period, and a random effect for subject within sequence. The analysis was conducted using PROC MIXED. The ability of CT1812 to rapidly restore synapse number to normal was expected to result in a decrease in EEG theta p

Global Relative Theta Power Day 1

Group	Value	95% CI
Placebo	0.2133	± 0.06158
CT1812	0.2071	± 0.08209

Global Relative Theta Power Day 29

Group	Value	95% CI
Placebo	0.2276	± 0.07872
CT1812	0.1971	± 0.07569

Change from Day 1 to Day 29

Group	Value	95% CI
Placebo	0.0104	± 0.03210
CT1812	-0.0100	± 0.04280

Changes in Predose CT1812 Plasma Concentrations. Primary · Baseline through Day 84: Pre and Post- Dose on Days 1, 29 AND Pre Dose Days 8, 15, 22.

For the measurements of pre-dose and post-dose plasma concentrations of CT1812, samples were collected 1± 0.25 hour predose. Single concentrations of CT1812 at selected predose and post-dose time points were reported.

Period Day 1, Predose

Group	Value	95% CI
CT1812	0.00	± 0.000

Period Day 1, Post-dose

Group	Value	95% CI
CT1812	179.64	± 136.717

Period Day 8, Predose

Group	Value	95% CI
CT1812	25.49	± 25.017

Period Day 15, Predose

Group	Value	95% CI
CT1812	14.93	± 7.826

Period Day 22, Predose

Group	Value	95% CI
CT1812	13.76	± 8.000

Period Day 29, Predose

Group	Value	95% CI
CT1812	14.08	± 8.984

Period Day 29, Post-dose

Group	Value	95% CI
CT1812	169.20	± 246.150

Changes in Predose CT1812 Plasma Concentrations. Primary · Baseline through Day 84: Pre and Post- Dose on Days 1, 29 AND Pre Dose Days 8, 15, 22.

Period Day 1, Post-dose

Group	Value	95% CI
CT1812	161.50	4.1 – 406.0

Period Day 8, Predose

Group	Value	95% CI
CT1812	23.05	2.5 – 106.0

Period Day 15, Predose

Group	Value	95% CI
CT1812	13.20	2.9 – 28.6

Period Day 22, Predose

Group	Value	95% CI
CT1812	12.40	3.6 – 28.8

Period Day 29, Predose

Group	Value	95% CI
CT1812	12.60	2.6 – 36.0

Period Day 29, Post-dose

Group	Value	95% CI
CT1812	96.35	7.5 – 949.0

Adverse events — posted to ClinicalTrials.gov

Time frame: 126 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/15 (0%)

Deaths: 0/15

CT1812

Serious: 0/16 (0%)

Deaths: 0/16

Other adverse events (15 terms — click to expand)

Reaction	System	Placebo	CT1812
Procedural headache	Injury, poisoning and procedural complications	—	—
Nausea	Gastrointestinal disorders	—	—
Headache	Nervous system disorders	—	—
Hematoma	Vascular disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Bone contusion	Injury, poisoning and procedural complications	—	—
Burns first degree	Injury, poisoning and procedural complications	—	—
Post procedural contusion	Injury, poisoning and procedural complications	—	—
Blood creatinine increased	Investigations	—	—
Hepatic enzyme increased	Investigations	—	—
Paraesthesia	Nervous system disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Corona virus infection	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—

Data from ClinicalTrials.gov NCT04735536 adverse events section.

Sponsor's own description

This is a single-site, randomized, double-blind, placebo-controlled, 29-day, 2-period crossover Phase 2 study of 1 dose level of CT1812 (active) or placebo in adults with mild to moderate AD.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Alzheimer's disease drug development pipeline: 2022.
Cummings J, Lee G, Nahed P, Kambar MEZN, et al · · 2022 · cited 369× · PMID 35516416 · DOI 10.1002/trc2.12295
Alzheimer's disease drug development pipeline: 2023.
Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2023 · cited 326× · PMID 37251912 · DOI 10.1002/trc2.12385
Alzheimer's and Parkinson's disease therapies in the clinic.
Chopade P, Chopade N, Zhao Z, Mitragotri S, et al · · 2023 · cited 96× · PMID 36684083 · DOI 10.1002/btm2.10367
Targeting Sigma Receptors for the Treatment of Neurodegenerative and Neurodevelopmental Disorders.
Malar DS, Thitilertdecha P, Ruckvongacheep KS, Brimson S, et al · · 2023 · cited 39× · PMID 37166702 · DOI 10.1007/s40263-023-01007-6
Sigma-2 Receptors-From Basic Biology to Therapeutic Target: A Focus on Age-Related Degenerative Diseases.
Lizama BN, Kahle J, Catalano SM, Caggiano AO, et al · · 2023 · cited 38× · PMID 37047224 · DOI 10.3390/ijms24076251
Discovery of Investigational Drug CT1812, an Antagonist of the Sigma-2 Receptor Complex for Alzheimer's Disease.
Rishton GM, Look GC, Ni ZJ, Zhang J, et al · · 2021 · cited 29× · PMID 34531947 · DOI 10.1021/acsmedchemlett.1c00048
The Sigma Receptors in Alzheimer's Disease: New Potential Targets for Diagnosis and Therapy.
Wang T, Jia H. · · 2023 · cited 19× · PMID 37569401 · DOI 10.3390/ijms241512025
A phase 1b randomized clinical trial of CT1812 to measure Aβ oligomer displacement in Alzheimer's disease using an indwelling CSF catheter.
LaBarbera KM, Sheline YI, Izzo NJ, Yuede CM, et al · · 2023 · cited 19× · PMID 37173791 · DOI 10.1186/s40035-023-00358-w

Verify or expand the search:

Other trials of CT1812

Trials testing the same drug.

NCT05225415 — Study to Evaluate the Safety, Tolerability and Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy B · Phase 2 · completed
NCT05248672 — Study to Assess the Pharmacokinetics of CT1812 in Older Healthy Volunteers · Phase 1 · completed
NCT03507790 — A Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease. · Phase 2 · completed
NCT03522129 — Study to Evaluate the Effect of CT1812 Treatment on Amyloid Beta Oligomer Displacement Into CSF in Subjects With Mild to · Phase 1 · completed
NCT03716427 — Drug Interaction Study of CT1812 in Healthy Volunteers · Phase 1 · completed

Other recruiting trials for Alzheimer Disease

Currently open trials in the same condition.

NCT07290387 — Tele-Savvy for Latino Caregivers · NA · recruiting
NCT07178210 — Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease · NA · recruiting
NCT07294885 — Deep Cervical LymphatIc-Venous Anastomosis for Alzheimer's Disease · NA · recruiting
NCT06937229 — A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3) · Phase 3 · recruiting
NCT06930560 — HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms · NA · recruiting

Other Cognition Therapeutics trials

Trials by the same sponsor.

NCT05893537 — Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy (GA) Secondary to Dry A · Phase 2 · terminated
NCT05225415 — Study to Evaluate the Safety, Tolerability and Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy B · Phase 2 · completed
NCT05248672 — Study to Assess the Pharmacokinetics of CT1812 in Older Healthy Volunteers · Phase 1 · completed
NCT05225389 — Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of CT1812 in Healthy Adult Male Subjects · Phase 1 · completed
NCT03507790 — A Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease. · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04735536 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cognition Therapeutics
Last refreshed: 29 November 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04735536.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing