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Trial record 2 of 2867 for:    cognition therapeutics

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

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by Cognition Therapeutics
Sponsor:
Information provided by (Responsible Party):
Cognition Therapeutics
ClinicalTrials.gov Identifier:
NCT02907567
First received: September 5, 2016
Last updated: December 10, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
Alzheimer's Disease Drug: CT1812 Drug: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase I Study of the Safety & Pharmacokinetics of Two Doses of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Cognition Therapeutics:

Primary Outcome Measures:
  • Incidence and review of Treatment Emergent Adverse Events [ Time Frame: Up to 30 days ]
    Treatment Emergent Adverse Events will be assessed by reviewing: Physical Exams; monitoring of vital signs, ECGs, and clinical and laboratory assessments


Estimated Enrollment: 16
Study Start Date: September 2016
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Treatment-Low
6 subjects randomized to 280 mg (Low) CT1812
Drug: CT1812
Active study drug
Other Name: Study Drug
Active Comparator: Active Treatment-High
6 subjects randomized to 560 mg (High) CT1812
Drug: CT1812
Active study drug
Other Name: Study Drug
Placebo Comparator: Placebo
4 subjects randomized to matching placebo of CT1812
Drug: Placebo
non-active study drug
Other Name: Matching placebo

Detailed Description:
Screening procedures will occur up to 42 days. Eligible subjects will randomized at the clinic on Day 1 and receive the first dose of study drug. Dosing for 28 days thereafter off-site and a total of 5 clinic visits over the treatment period for safety and lab assessments. Then a 7 day post-treatment completion follow-up visit (Day 35) and End of Study for last safety assessments (Day 49).
  Eligibility

Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Previous decline in cognition for more than six months.
  4. Neuroimaging (MRI) obtained within the previous 6 months or during screening, consistent with the clinical diagnosis of Alzheimer's disease.
  5. MMSE 18-26 inclusive.
  6. No active depression and a Geriatric Depression Score (GDS) of < 6.
  7. Modified Hachinski Ischemia score ≤ 4.
  8. Formal education of eight or more years.
  9. 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.
  10. Concurrent use of acetylcholinesterase inhibitors or memantine must be stable for 90 days prior to screening and not expected to change.

Exclusion Criteria:

  1. 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).
  2. Clinical or laboratory findings consistent with:

    1. Other primary degenerative dementia,
    2. Other neurodegenerative condition
    3. Seizure disorder
    4. Other infectious, metabolic or systemic diseases affecting the central nervous system
  3. A current DSM-V diagnosis of active major depression, schizophrenia or bipolar disorder.
  4. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02907567

Contacts
Contact: Sarah Harvey sarah.harvey@florey.edu.au

Locations
Australia, Queensland
Dr. Phillip Morris Recruiting
Southport, Queensland, Australia
Contact: Phillip Morris, MD    0422545753    plpmorris1@gmail.com   
Contact: Judith Coote       Judith.Coote@healthscope.com.au   
Australia, Victoria
Austin Health Recruiting
Ivanhoe, Victoria, Australia, 3079
Contact: Michael Woodward, MD       Michael.WOODWARD@austin.org.au   
Contact: Lauren Grimwood       Lauren.GRIMWOOD@austin.org.au   
Epworth Hospital Recruiting
Melbourne, Victoria, Australia, 3121
Contact: Richard Gerraty, MD       rgerraty@mac.com   
Contact: Donna McCallum       Donna.McCallum@epworth.org.au   
The Royal Melbourne Hospital Hospital Recruiting
Parkville, Victoria, Australia, 3050
Contact: Terence O'Brien, MD       obrientj@unimelb.edu.au   
Contact: Lucy Vivash       lucy.vivash@mh.org.au   
Sponsors and Collaborators
Cognition Therapeutics
Investigators
Principal Investigator: Michael Woodward, MD Austin Health
  More Information

Responsible Party: Cognition Therapeutics
ClinicalTrials.gov Identifier: NCT02907567     History of Changes
Other Study ID Numbers: COG0102
Study First Received: September 5, 2016
Last Updated: December 10, 2016

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 21, 2017