GAIN Trial: Phase 2/3 Study of COR388 in Subjects With Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT03823404|
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : June 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: COR388 capsule Drug: Placebo capsule||Phase 2 Phase 3|
This is a randomized, double-blind, placebo-controlled study that will assess the efficacy, safety, and tolerability of 2 dose levels of COR388 oral capsules in subjects with probable AD dementia according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria. The study will enroll approximately 573 generally healthy male and female subjects ≥55 and ≤80 years of age. Enrolled subjects must have a documented diagnosis of mild to moderate AD dementia. The subject should not have other conditions or brain imaging abnormalities that can explain the symptoms of dementia. All subjects will be encouraged to have LPs (during screening, week 24 and week 48) in the absence of medical conditions that can increase the risk of the procedure in the opinion of the Investigator. Cerebrospinal fluid (CSF), saliva, and blood will be analyzed for measurements of biomarkers of AD and neuroinflammation, and for the presence of bacterial deoxyribonucleic acid (DNA) of Porphyromonas gingivalis (P. gingivalis [Pg]). A subset of sites will monitor subjects for clinical evidence of periodontitis at baseline, 24 and 48 weeks.
The study will consist of 3 periods: a screening period of up to 6 weeks, a treatment period of up to 48 weeks, and a safety follow-up period of 6 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||573 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||GAIN Trial: A Randomized, Double-Blind, Placebo-Controlled Study of COR388 in Subjects With Alzheimer's Disease|
|Actual Study Start Date :||March 28, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
|Experimental: COR388 80 mg bid||
Drug: COR388 capsule
|Experimental: COR388 40 mg bid||
Drug: COR388 capsule
|Placebo Comparator: Placebo bid||
Drug: Placebo capsule
- Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) [ Time Frame: Baseline to Week 48 ]Mean change in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) from baseline to the end of treatment period. ADAS-Cog 11 measures cognitive functions and non-cognitive functions such as mood and behavior. Total scores range from 0-70, with higher scores (≥ 18) indicating greater cognitive impairment. ADAS-Cog 11 score increases by 2-4 points per year on average in subjects with mild to moderate Alzheimer's Disease. A treatment period of 48 weeks was selected to allow sufficient time to demonstrate at least 2.5 points difference between active treatment and placebo on ADAS-Cog 11 at the end of the treatment period.
- CDR-SB [ Time Frame: Baseline to Week 48 ]Change in Clinical Dementia Rating-Sum of Boxes (CDR-SB).
- ADCS-ADL [ Time Frame: Baseline to Week 48 ]Change in Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL).
- Mini-Mental State Examination (MMSE) [ Time Frame: Baseline to Week 48 ]Change in MMSE.
- Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline to Week 48 ]Change in NPI.
- Cerebrospinal fluid (CSF) Porphyromonas gingivalis DNA fragments [ Time Frame: Baseline to Week 48 ]Change in CSF Porphyromonas gingivalis DNA fragments.
- Winterlight Speech Assessment [ Time Frame: Baseline to Week 48 ]Change in Winterlight Speech Assessment.
- Magnetic resonance imaging [ Time Frame: Baseline to Week 48 ]Change in magnetic resonance imaging.
- Periodontal (or gum) pocket depth [ Time Frame: Baseline to Week 48 ]Change in periodontal (or gum) pocket depth.
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): NCT03823404
|Contact: Michael J Detke, MD, PhDfirstname.lastname@example.org|