Study to Evaluate the Effect of CT1812 Treatment on Amyloid Beta Oligomer Displacement Into CSF in Subjects With Mild to Moderate Alzheimer's Disease

NCT03522129 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: COG0104
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multi-center, Phase 1b, randomized, double-blind, placebo-controlled parallel-group trial in adults with mild to moderate AD.

Conditions

Alzheimer Disease

Keywords

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Measuring the displacement of Amyloid beta oligomers into cerebrospinal fluid (CSF)

  evidence of oligomer displacement as demonstrated by a clear rise in CSF oligomer concentration relative to baseline and placebo

  48 hours

Study Arms (4)

Active Treatment- CT1812 560 mg

ACTIVE COMPARATOR

Drug: CT1812

Active Treatment- CT1812 280 mg

ACTIVE COMPARATOR

Drug: CT1812

Active Treatment- CT1812 90 mg

ACTIVE COMPARATOR

Drug: CT1812

Placebo Comparator - Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CT1812 DRUG

Active Study Drug

Also known as: Study Drug

Active Treatment- CT1812 280 mg; Active Treatment- CT1812 560 mg; Active Treatment- CT1812 90 mg

Placebo DRUG

Non-active study drug

Also known as: Matching Placebo

Placebo Comparator - Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects may be included in the study only if they meet all of the following criteria:
• Men, and women of non-childbearing potential, 50-85 years of age inclusively, with a diagnosis of mild to moderate Probable Alzheimer's Disease Dementia according to the 2011 NIA-AA criteria and at least a 6 month decline in cognitive function documented in the medical record.
• a. Non-childbearing potential for women is defined as postmenopausal \[last natural menses greater than 24 months; in women under age 55, menopausal status will be documented with serum follicle stimulating hormone (FSH) test\] or undergone a documented bilateral tubal ligation or hysterectomy
• b. Male participants who are sexually active with a woman of childbearing potential must agree to use condoms during the trial 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.

You may not qualify if:

• MMSE 18-26 inclusive. Subjects must, in the opinion of the investigator, be able to comply with study procedures and must understand the consent process. The investigator will use his or her clinical judgment in conjunction with the cognitive screening assessments to determine whether the subject meets these criteria in a manner that is consistent with local clinical practice and standards. Subjects with borderline low MMSE at screening may undergo repeat MMSE administration if extenuating circumstances were present at original assessment.
• A positive amyloid scan (florbetaben F18, florbetapir F18, or flutametamol F18) at screening or within prior 12 months, as read by the certified, site-designated PET scan reader.
• Must consent to apolipoprotein E (ApoE) genotyping.
• Subjects must have a caregiver or study partner who can participate in all clinic visits.
• Patients living at home or in the community (assisted living acceptable).
• Able to swallow CT1812 capsules.
• Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening.
• Subjects must be capable of providing either written informed consent to the study procedures and for use of protected health information \[Health Insurance Portability and Accountability Act (HIPAA) Authorization, if applicable\]. Written informed consent also shall be obtained from the responsible caregiver or study partner. All consent processes must be undertaken in the presence of a witness and prior to any study procedures.
• Subjects shall be generally healthy with mobility (ambulatory or ambulatory-aided, i.e., walker or cane), vision and hearing (hearing aid permissible) sufficient for compliance with testing procedures.
• Must be able to complete all screening evaluations.
• Subjects will be excluded from the study if any of the following conditions apply:
• Hospitalization or change of chronic concomitant medication within one month prior to screening.
• Patients living in a continuous care nursing facility
• Screening MRI 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:

Sponsors & Collaborators

• Cognition Therapeutics: lead

Study Sites (2)

Clinilabs Drug Development Corporation

New York, New York, 07724, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• LaBarbera KM, Sheline YI, Izzo NJ, Yuede CM, Waybright L, Yurko R, Edwards HM, Gardiner WD, Blennow K, Zetterberg H, Borjesson-Hanson A, Morgan R, Davis CS, Guttendorf RJ, Schneider LS, DeKosky S, LeVine H 3rd, Grundman M, Caggiano AO, Cirrito JR, Catalano SM, Hamby ME. A phase 1b randomized clinical trial of CT1812 to measure Abeta oligomer displacement in Alzheimer's disease using an indwelling CSF catheter. Transl Neurodegener. 2023 May 12;12(1):24. doi: 10.1186/s40035-023-00358-w. No abstract available.

  PMID: 37173791 DERIVED

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

Study Officials

• Alyssa Galley

  Cognition Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind for study site and participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1b, randomized, double-blind, placebo-controlled parallel-group trial in adults with mild to moderate AD.

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 11, 2018
• Study Start: May 30, 2018
• Primary Completion: February 6, 2019
• Study Completion: February 6, 2019
• Last Updated: January 12, 2022

Record last verified: 2022-01

Locations

US (2)