A Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease.

NCT03507790 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: COG0201R01AG0586602022-002326-27
• Study Type: interventional
• Target: 153
• Locations: 5 countries
• Sites: 32

Brief Summary

This is a multi-center, randomized, double-blind, placebo-controlled, parallel group 36 week multicenter Phase 2 study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease (AD).

Conditions

Mild to Moderate Alzheimer's Disease

Keywords

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• Number of Study Participants With at Least One Mild, Moderate, or Severe Treatment Emergent Adverse Events (TEAEs)

  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 27.0.TEAEs are events that occurred or worsened on or after the first application of study drug. Participants are counted once for each system organ class (SOC) and once for each preferred term (PT).

  Up to 210 Days

• Number of Study Participants With at Least One Treatment Emergent Adverse Events (TEAs) and Serious Adverse Events (SAEs).

  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 27.0.TEAEs are events that occurred or worsened on or after the first application of study drug. Participants are counted once for each system organ class (SOC) and once for each preferred term (PT).

  Up to 210 Days

Secondary Outcomes (2)

• Change From Baseline in the Cerebrospinal Fluid (CSF) Biomarkers

  Baseline to Day 182

• Amyloid Beta 1-42/Amyloid Beta 1-40 (Aβ42/40) in the Cerebrospinal Fluid (CSF) Biomarkers

  Baseline to Day 182

Study Arms (3)

Active Treatment- CT1812 100 mg

ACTIVE COMPARATOR

CT1812 at a dose of 100 mg

Drug: CT1812

Active Treatment- CT1812 300 mg

ACTIVE COMPARATOR

CT1812 at a dose of 300mg

Drug: CT1812

Placebo Comparator - Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

CT1812 DRUG

Active Study Drug

Also known as: Study Drug, zervimesine

Active Treatment- CT1812 100 mg; Active Treatment- CT1812 300 mg

Placebo DRUG

Non-active study drug

Also known as: Matching Placebo

Placebo Comparator - Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men, and women of non-childbearing potential, 50-85 years of age inclusively, with a diagnosis of mild to moderate Alzheimer's disease according to the 2011 NIA-AA criteria and at least a 6 month decline in cognitive function documented in the medical record.
• i) Non-childbearing potential for women is defined as postmenopausal (last natural menses greater than 24 months) or undergone a documented bilateral tubal ligation or hysterectomy. If last natural menses less than 24 months, a serum FSH value confirming post-menopausal status can be employed.
• ii) Male participants who are sexually active with a woman of child-bearing potential must agree to use condoms during the trial and for 3 months after last dose unless the woman is using an acceptable means of birth control. Acceptable forms of birth control include abstinence, birth control pills, or any double combination of: intrauterine device (IUD), male or female condom, diaphragm, sponge, and cervical cap.
• Diagnostic confirmation by amyloid PET with florbetaben or another approved amyloid PET ligand. Previous amyloid imaging study with a positive result will be accepted. If none is available, then amyloid PET will be conducted during screening. Diagnostic confirmation by a CSF sample collected at the screening visit lumbar puncture in place of amyloid PET will also be acceptable

You may not qualify if:

• MMSE 18-26 inclusive.
• Screening MRI (or historical MRI, if applicable) of the brain indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct \>1 cm3, \>3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor such as meningioma). If a small incidental meningioma is observed, the medical monitor may be contacted to discuss eligibility..
• Clinical or laboratory findings consistent with:
• Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
• Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.).
• Seizure disorder.
• Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, other laboratory values etc.).
• A current DSM-V diagnosis of active major depression, schizophrenia or bipolar disorder. Subjects with depressive symptoms successfully managed by a stable dose of an antidepressant are allowed entry.
• Clinically significant, advanced or unstable disease that may interfere with outcome evaluations.

Sponsors & Collaborators

• Cognition Therapeutics: lead
• National Institute on Aging (NIA): collaborator

Study Sites (32)

21st Century Neurology/ Xenoscience Inc.

Phoenix, Arizona, 85004, United States

Location

Imaging Endpoints

Scottsdale, Arizona, 85258, United States

Location

Ki Health Partners, LLC dba New England Institute for Clinical Research

Stamford, Connecticut, 06905, United States

Location

JEM Research Institute

Atlantis, Florida, 33462, United States

Location

Charter Research

Lady Lake, Florida, 32159, United States

Location

ClinCloud, LLC

Maitland, Florida, 32751, United States

Location

Allied Biomedical Research Institute

Miami, Florida, 33155, United States

Location

Compass Research LLC- Bioclinica Research

The Villages, Florida, 32162, United States

Location

ClinCloud

Viera, Florida, 32940, United States

Location

Alzheimer's Memory Center

Charlotte, North Carolina, 28270, United States

Location

The Ohio State University - Wexner

Columbus, Ohio, 43221-3502, United States

Location

Neuro Behavirol Clinical Research C

North Canton, Ohio, 44720, United States

Location

St Vincent's Hospital Sydney

Ivanhoe, Victoria, 3079, Australia

Location

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

Melbourne Health

Parkville, Victoria, 3050, Australia

Location

Australian Alzheimer's Research Foundation

Nedlands, Western Australia, 6009, Australia

Location

Neuro Health Centrum ltd

Brno, 628 00, Czechia

Location

NeuropsychiatrieHK S.R.O

Hradec Králové, 503 41, Czechia

Location

A-Shine S.R.O

Pilsen, 30100, Czechia

Location

Clintrial S.R.O

Prague, 100 00, Czechia

Location

Neuropsychiatrie s.r.o.

Prague, 16 000, Czechia

Location

Forbeli S.R.O

Prague, 160 00, Czechia

Location

INEP

Prague, 18600, Czechia

Location

Vestra Clinics

Rychnov nad Kněžnou, 51601, Czechia

Location

Brain Research Den Bosch

's-Hertogenbosch, 5223 LA, Netherlands

Location

Brain Research Center Amsterdam

Amsterdam, 1081 GN, Netherlands

Location

Brain Research Center Zwolle

Zwolle, 8025 AZ, Netherlands

Location

Fundación ACE

Barcelona, 08028, Spain

Location

Hospital Clinico Universitario Virgen De La Arrixaca

El Palmar, 30120, Spain

Location

Centro de Salud San Juan

Salamanca, 37005, Spain

Location

Hospital Victoria EUGENIA. Unidad de Neurociencias.

Seville, 41009, Spain

Location

Fundación Neuropolis - Hospital Viamed Montecanal

Zaragoza, 5000, Spain

Location

Related Publications (1)

• Lizama BN, North HA, Pandey K, Williams C, Duong D, Cho E, Di Caro V, Ping L, Blennow K, Zetterberg H, Lah J, Levey AI, Grundman M, Caggiano AO, Seyfried NT, Hamby ME. An interim exploratory proteomics biomarker analysis of a phase 2 clinical trial to assess the impact of CT1812 in Alzheimer's disease. Neurobiol Dis. 2024 Sep;199:106575. doi: 10.1016/j.nbd.2024.106575. Epub 2024 Jun 22.

  PMID: 38914170 DERIVED

Related Links

• Shine Study Information

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Results Point of Contact

• Title: Dr. Anthony Caggiano
• Organization: Cogntion Therapeutics Inc

acaggiano@cogrx.com

914-221-6730

Study Officials

• Anthony Caggiano, MD

  Cognition Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a multi-center Phase 2, randomized, double-blind, placebo-controlled, parallel-group study.

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: April 25, 2018
• Study Start: October 10, 2018
• Primary Completion: May 29, 2024
• Study Completion: May 29, 2024
• Last Updated: August 11, 2025
• Results First Posted: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (12); NL (3); CZ (8); ES (5); AU (4)