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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02907567
Recruitment Status : Completed
First Posted : September 20, 2016
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Cognition Therapeutics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: CT1812 Drug: Placebo Phase 1 Phase 2

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
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
Actual Study Start Date : September 2016
Actual Primary Completion Date : August 24, 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907567


Locations
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Australia, Queensland
Dr. Phillip Morris
Southport, Queensland, Australia
Australia, Victoria
Austin Health
Ivanhoe, Victoria, Australia, 3079
Epworth Hospital
Melbourne, Victoria, Australia, 3121
The Royal Melbourne Hospital Hospital
Parkville, Victoria, Australia, 3050
Sponsors and Collaborators
Cognition Therapeutics
Investigators
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Principal Investigator: Michael Woodward, MD Austin Health
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cognition Therapeutics
ClinicalTrials.gov Identifier: NCT02907567    
Other Study ID Numbers: COG0102
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders