Effects of Sulforaphane in Patients With Prodromal to Mild Alzheimer's Disease
NCT04213391 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2020-05-12
Summary
In this proposed study, the investigators will evaluate the efficacy, safety and related mechanism of sulforaphane in treatment of Alzheimer's disease (AD). The study will recruit 160 AD patients, and then these patients will be randomized to sulforaphane group or placebo group (80 patients per arm) for 24 weeks clinic trial. Clinical efficacy and safety assessment will be done at screen/baseline, 4 week, 12 week, and 24 week. The specific aims are to compare sulforaphane versus placebo on: clinical core symptoms; biological samples also will be collected, and stored to research related mechanisms. During the study period, safety index including blood and urine routine, liver and kidney function, coagulation index and clinical effect index about neuropsychological scales will be recorded.
Conditions
- Alzheimer Disease
Interventions
- DIETARY_SUPPLEMENT
-
sulforaphane
Sulforaphane take 2550mg once a day.
- DIETARY_SUPPLEMENT
-
Placebo
Placebo take 2550mg once a day.
Sponsors & Collaborators
-
Second Affiliated Hospital, School of Medicine, Zhejiang University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-05-10
- Primary Completion
- 2022-11-01
- Completion
- 2022-12-01
Countries
- China
Study Locations
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