Clinical Trial of CT1812 in Mild to Moderate Alzheimer's Disease

NCT02907567 | Completed Phase 1 DMC

• 1 other identifier: COG0102
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 4

Brief Summary

This is a multi-center, randomized, double-blind, placebo-controlled, parallel group study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease to evaluate the safety and tolerability of oral CT1812, administered for 28 days. This trial may include up to 8 qualified investigator sites in Australia.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Incidence and review of Treatment Emergent Adverse Events

  Treatment Emergent Adverse Events will be assessed by reviewing: Physical Exams; monitoring of vital signs, ECGs, and clinical and laboratory assessments

  Up to 30 days

Study Arms (3)

Active Treatment-Low

ACTIVE COMPARATOR

6 subjects randomized to 280 mg (Low) CT1812

Drug: CT1812

Active Treatment-High

ACTIVE COMPARATOR

6 subjects randomized to 560 mg (High) CT1812

Drug: CT1812

Placebo

PLACEBO COMPARATOR

4 subjects randomized to matching placebo of CT1812

Drug: Placebo

Interventions

CT1812 DRUG

Active study drug

Also known as: Study Drug

Active Treatment-High; Active Treatment-Low

Placebo DRUG

non-active study drug

Also known as: Matching placebo

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:

• Willing and able to provide written informed consent prior to initiation of any study-related procedures. For subjects unable to provide written consent, consent will be provided by the Person Responsible per local regulations.
• Men and women, 50-80 years in age inclusively with a diagnosis of mild to moderate Alzheimer's disease according to the 2011 NIA-AA. Women must be neither pregnant nor nursing, and are either surgically sterile, postmenopausal or premenopausal using an acceptable method of contraception.
• Previous decline in cognition for more than six months.
• Neuroimaging (MRI) obtained within the previous 6 months or during screening, consistent with the clinical diagnosis of Alzheimer's disease.
• MMSE 18-26 inclusive.
• No active depression and a Geriatric Depression Score (GDS) of \< 6.
• Modified Hachinski Ischemia score ≤ 4.
• Formal education of eight or more years.
• Living at home or in a community setting (assisted living) without continuous nursing care. Each subject must have a reliable caregiver who sees them at least 3 times weekly, can oversee the administration of study drug, and is willing and able to participate in all clinic visits and some study procedures. Responsible caregiver must provide written informed consent to participate.
• Concurrent use of acetylcholinesterase inhibitors or memantine must be stable for 90 days prior to screening and not expected to change.

You may not qualify if:

• History of or screening brain MRI scan 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).
• Clinical or laboratory findings consistent with:
• Other primary degenerative dementia,
• Other neurodegenerative condition
• Seizure disorder
• Other infectious, metabolic or systemic diseases affecting the central nervous system
• A current DSM-V diagnosis of active major depression, schizophrenia or bipolar disorder.
• Clinically significant, advanced or unstable disease that may interfere with outcome measures, and which may bias the assessment of the clinical or mental status of the patient or put the patient at special risk

Sponsors & Collaborators

• Cognition Therapeutics: lead

Study Sites (4)

Dr. Phillip Morris

Southport, Queensland, Australia

Location

Austin Health

Ivanhoe, Victoria, 3079, Australia

Location

Epworth Hospital

Melbourne, Victoria, 3121, Australia

Location

The Royal Melbourne Hospital Hospital

Parkville, Victoria, 3050, Australia

Location

Related Publications (1)

• Izzo NJ, Yuede CM, LaBarbera KM, Limegrover CS, Rehak C, Yurko R, Waybright L, Look G, Rishton G, Safferstein H, Hamby ME, Williams C, Sadlek K, Edwards HM, Davis CS, Grundman M, Schneider LS, DeKosky ST, Chelsky D, Pike I, Henstridge C, Blennow K, Zetterberg H, LeVine H 3rd, Spires-Jones TL, Cirrito JR, Catalano SM. Preclinical and clinical biomarker studies of CT1812: A novel approach to Alzheimer's disease modification. Alzheimers Dement. 2021 Aug;17(8):1365-1382. doi: 10.1002/alz.12302. Epub 2021 Feb 8.

  PMID: 33559354 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

• Michael Woodward, MD

  Austin Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: September 20, 2016
• Study Start: September 1, 2016
• Primary Completion: August 24, 2017
• Study Completion: September 1, 2017
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

AU (4)