Back to resultsClinical Trial of CT1812 in Mild to Moderate Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
CT1812
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Dr. Phillip Morris
- Austin Health
- Epworth Hospital
- The Royal Melbourne Hospital Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Active Treatment-Low
Active Treatment-High
Placebo
Arm Description
6 subjects randomized to 280 mg (Low) CT1812
6 subjects randomized to 560 mg (High) CT1812
4 subjects randomized to matching placebo of CT1812
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02907567
First Posted
September 5, 2016
Last Updated
July 24, 2018
Sponsor
Cognition Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT02907567
Brief Title
Clinical Trial of CT1812 in Mild to Moderate Alzheimer's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
August 24, 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cognition Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Treatment-Low
Arm Type
Active Comparator
Arm Description
6 subjects randomized to 280 mg (Low) CT1812
Arm Title
Active Treatment-High
Arm Type
Active Comparator
Arm Description
6 subjects randomized to 560 mg (High) CT1812
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
4 subjects randomized to matching placebo of CT1812
Intervention Type
Drug
Intervention Name(s)
CT1812
Other Intervention Name(s)
Study Drug
Intervention Description
Active study drug
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matching placebo
Intervention Description
non-active study drug
Primary Outcome Measure Information:
Title
Incidence and review of Treatment Emergent Adverse Events
Description
Treatment Emergent Adverse Events will be assessed by reviewing: Physical Exams; monitoring of vital signs, ECGs, and clinical and laboratory assessments
Time Frame
Up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Woodward, MD
Organizational Affiliation
Austin Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Phillip Morris
City
Southport
State/Province
Queensland
Country
Australia
Facility Name
Austin Health
City
Ivanhoe
State/Province
Victoria
ZIP/Postal Code
3079
Country
Australia
Facility Name
Epworth Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Facility Name
The Royal Melbourne Hospital Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
33559354
Citation
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.
Results Reference
derived
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Clinical Trial of CT1812 in Mild to Moderate Alzheimer's Disease
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