An interventional study of sulforaphane and Placebo in Alzheimer Disease, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-05-12.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
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.
In this proposed study, the investigators will evaluate the efficacy, safety and related mechanism of sulforaphane in treatment of AD. The study will recruit 160 AD patients, 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, 24 week. The specific aims are to compare sulforaphane versus placebo on: 1) clinical core symptoms; The investigators hypothesize that (1) sulforaphane is superior to placebo in the treatment of clinical symptoms in patients with AD, measured by the ADAS-cog, MMSE Scale, Moca; (2) Biological samples will be collected, and stored so that the hypothesis sulforaphane may alter oxidative stress indexes or inflammatory biomarkers, and influence histone deacetylase inhibitor mechanism or inflammatory mechanism et al that may be significantly correlated with clinical improvement. (3) Safety index including blood and urine routine, liver and kidney function, coagulation index and clinical effect index about neuropsychological scales will be recorded.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 160 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The patients will take sulforaphane for 24 weeks, 2550mg once a day.
Dietary Supplement: sulforaphane
The patients will take placebo for 24 weeks, 2550mg once a day.
Dietary Supplement: Placebo
Sulforaphane take 2550mg once a day.
Placebo take 2550mg once a day.
The Alzheimer's Disease Assessment Scale
The Alzheimer's Disease Assessment Scale (ADAS-cog) will be performed to test the cognition of patients at the enrollment, week 12 and week 24. The score ranges from 0 to 75，and higher values represent a better outcome.
Time frame: From baseline to 24 weeks
Alzheimer's Disease Collaborative research group-Activities of Daily Living scores.
Alzheimer's Disease Collaborative research group-Activities of Daily Living scores (ADCS-ADL) will be performed to test the activities of patients at the enrollment,week 6 and week12.The score ranges from 0 to 54，and higher values represent a better outcome.
Time frame: From baseline to 24 weeks
Neuropsychiatric Inventory scores
Neuropsychiatric Inventory scores (NPI) will be performed to test the mental symptoms of patients at the enrollment and week12.The score ranges from 0 to 144，and higher values represent a worse outcome.
Time frame: baseline time to 24 weeks
Mini-Mental State Examination scores
Mini-Mental State Examination scores(MMSE) will be performed to test the cognition of patients at the enrollment and week12.The score ranges from 0 to 30，and higher values represent a better outcome.
Time frame: baseline time to 24 weeks
Montreal Cognitive Assessment scores
Montreal Cognitive Assessment scores (MoCA) will be performed to test the cognition of patients at the enrollment and week12.The score ranges from 0 to 30，and higher values represent a better outcome.
Time frame: baseline time to 24 weeks
Clinician Interview-Based Impression of Change plus caregiver input
Clinician Interview-Based Impression of Change plus caregiver input (CIBIC-plus) is widely used in antidementia drug trials. It comprises Likert scales for disease severity and changes, and written accounts summarizing semistructured interviews evaluating behavior, cognition, and function.
Time frame: baseline time to 24 weeks
Oxidative stress indexes
The change of Oxidative stress indexes as tested by Oxidative stress indexes detection kit
Time frame: At baseline and 24 week/endpoint
Epigenetics indicators
The change of Epigenetics indicators as tested by Epigenetics indicators
Time frame: At baseline and 24 week/endpoint
Cytokines & Chemokines
The change of Cytokines \& Chemokines as tested by Cytokines \& Chemokines detection kit
Time frame: At baseline and 24 week/endpoint
Metabolites
The change of Metabolites as tested by Metabolites detection kit
Time frame: At baseline and 24 week/endpoint
RNA expression
The change of RNA expression as tested by RNA expression detection kit
Time frame: At baseline and 24 week/endpoint
Intestinal microflora
The change of intestinal microflora as tested by Metagenomic technique
Time frame: At baseline and 24 week/endpoint
Plan to share: Undecided
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Second Affiliated Hospital, School of Medicine, Zhejiang University