| Trial ID: | L7203 |
| Source ID: | NCT02502253
|
| Associated Drug: |
Grape Seed Polyphenolic Extract, Resveratrol
|
| Title: |
BDPP Treatment for Mild Cognitive Impairment (MCI) and Prediabetes or Type 2 Diabetes Mellitus (T2DM)
|
| Acronym: |
BDPP
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Mild Cognitive Impairment|Alzheimer's Disease
|
| Interventions: |
DRUG: grape seed polyphenolic extract, resveratrol
|
| Outcome Measures: |
Primary: Assessment of Adverse Events (AEs) and Serious Adverse Events (SAEs), 4 months|Confirm brain penetrance of BDPP by measuring levels of BDPP constituents in cerebrospinal fluid (CSF)., 4 months|Evaluate BDPP effect on mood with Neuropsychiatric Inventory and Cornell Scale for Depression in Dementia., 4 months|Evaluate BDPP effect on cognition with measures of memory, executive function, and attention measures (composite), 4 months |
|
| Sponsor/Collaborators: |
Sponsor: Johns Hopkins University | Collaborators: Icahn School of Medicine at Mount Sinai
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
14
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2015-06
|
| Completion Date: |
2022-06-01
|
| Results First Posted: |
|
| Last Update Posted: |
2022-07-22
|
| Locations: |
Johns Hopkins University, Baltimore, Maryland, 21224, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02502253
|
