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
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|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: CT1812 Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Active Comparator: Active Treatment-Low
6 subjects randomized to 280 mg (Low) CT1812
Active study drug
Other Name: Study Drug
Active Comparator: Active Treatment-High
6 subjects randomized to 560 mg (High) CT1812
Active study drug
Other Name: Study Drug
Placebo Comparator: Placebo
4 subjects randomized to matching placebo of CT1812
non-active study drug
Other Name: Matching placebo
- 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
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, Learn About Clinical Studies.
|Ages Eligible for Study:||50 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
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
|Dr. Phillip Morris|
|Southport, Queensland, Australia|
|Ivanhoe, Victoria, Australia, 3079|
|Melbourne, Victoria, Australia, 3121|
|The Royal Melbourne Hospital Hospital|
|Parkville, Victoria, Australia, 3050|
|Principal Investigator:||Michael Woodward, MD||Austin Health|
|Responsible Party:||Cognition Therapeutics|
|Other Study ID Numbers:||
|First Posted:||September 20, 2016 Key Record Dates|
|Last Update Posted:||July 26, 2018|
|Last Verified:||July 2018|
Central Nervous System Diseases
Nervous System Diseases