Effects of Sulforaphane in Patients With Prodromal to Mild Alzheimer's Disease
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ClinicalTrials.gov Identifier: NCT04213391 |
Recruitment Status : Unknown
Verified May 2019 by Second Affiliated Hospital, School of Medicine, Zhejiang University.
Recruitment status was: Recruiting
First Posted : December 30, 2019
Last Update Posted : May 12, 2020
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Condition or disease | Intervention/treatment | Phase |
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Alzheimer Disease | Dietary Supplement: sulforaphane Dietary Supplement: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Randomized,Double-blind, Placebo-controlled, Efficacy and Safety Study of Sulforaphane in Patients With Prodromal to Mild Alzheimer's Disease |
Estimated Study Start Date : | May 10, 2020 |
Estimated Primary Completion Date : | November 1, 2022 |
Estimated Study Completion Date : | December 1, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: sulforaphane group
The patients will take sulforaphane for 24 weeks, 2550mg once a day.
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Dietary Supplement: sulforaphane
Sulforaphane take 2550mg once a day. |
Placebo Comparator: Placebo group
The patients will take placebo for 24 weeks, 2550mg once a day.
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Dietary Supplement: Placebo
Placebo take 2550mg once a day. |
- The Alzheimer's Disease Assessment Scale [ Time Frame: From baseline to 24 weeks ]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.
- Alzheimer's Disease Collaborative research group-Activities of Daily Living scores. [ Time Frame: From baseline to 24 weeks ]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.
- Neuropsychiatric Inventory scores [ Time Frame: baseline time to 24 weeks ]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.
- Mini-Mental State Examination scores [ Time Frame: baseline time to 24 weeks ]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.
- Montreal Cognitive Assessment scores [ Time Frame: baseline time to 24 weeks ]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.
- Clinician Interview-Based Impression of Change plus caregiver input [ Time Frame: baseline time to 24 weeks ]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.
- Oxidative stress indexes [ Time Frame: At baseline and 24 week/endpoint ]The change of Oxidative stress indexes as tested by Oxidative stress indexes detection kit
- Epigenetics indicators [ Time Frame: At baseline and 24 week/endpoint ]The change of Epigenetics indicators as tested by Epigenetics indicators
- Cytokines & Chemokines [ Time Frame: At baseline and 24 week/endpoint ]The change of Cytokines & Chemokines as tested by Cytokines & Chemokines detection kit
- Metabolites [ Time Frame: At baseline and 24 week/endpoint ]The change of Metabolites as tested by Metabolites detection kit
- RNA expression [ Time Frame: At baseline and 24 week/endpoint ]The change of RNA expression as tested by RNA expression detection kit
- Intestinal microflora [ Time Frame: At baseline and 24 week/endpoint ]The change of intestinal microflora as tested by Metagenomic technique
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 1. Age range from 50 to 75 (including 50 and 75 years old), regardless of ethnic group or gender;
- 2. The subjects should be able to complete the cognitive ability measurement and other tests specified in the protocol;
- 3. Meeting the criteria for likely Alzheimer's Disease (AD) dementia (2011) by National Institute of Neurological Disorders and Strokes - Alzheimer's Disease and Related Diseases Association(NINCDS-ADRDA);
- 4. Patients with mild dementia: the total score of Mini-Mental State Examination (MMSE) : ≥22 points; Clinical Dementia Rating scale (CDR)score > or equal to 0.5 and < or equal to1;The MMSE score provides evidence of mild disease severity and the CDR-GS score indicates that the patients have noticeable amnestic (pAD) or cognitive and functional (mAD) deficits
- 5. The total score of the Hachinski Ischemic Score (HIS )was < 4.
- 6. Hamilton depression scale (17 items) total score ≤7 points;
- 7. Brain MRI shows a high likelihood of AD;
- 8. Before enrollment, patients should take a stable dose of dementia drugs (donepezil 5mg) ≥8 weeks;
- 9. The expected survival time is > 1 year;
- 10. Subjects should have a stable and reliable caregiver, or at least have frequent contact with the caregiver (at least 3 days per week and at least 2 hours per day), who will help patients participate in the whole study; Caregivers must accompany the subjects to the visit and assist in completing the relevant scale.
Exclusion Criteria:
- 1. Refuse to sign the inform consent form;
- 2. Other causes of dementia: known vascular, central nervous system infection ,Parkinson's disease, traumatic brain dementia, other physical and chemical factors; serious body disease , intracranial space-occupying lesions, endocrine system disease, such as thyroid disease, and a lack of vitamin B12, folic acid, or any other known causes of dementia.
- 3. Central nervous system diseases (including stroke, optic neuromyelitis, Parkinson's disease, epilepsy, etc.);
- 4. Obvious positive signs of nervous system examination;
- 5. Psychotic patients, including schizophrenia or other disorders with bipolar disorder, major depression or delirium;
- 6. Uncontrolled hypertension or hypotension during screening: systolic blood pressure ≥180(millimetres of mercury )mmHg or < 90mmhg, or diastolic blood pressure ≥120mmHg or < 60mmhg;
- 7. Unstable or severe diseases of the heart, lung, liver, kidney and hematopoietic system according to the judgment of the researchers;
- 8. Patients with incurable visual and auditory disorders that cannot complete neuropsychological tests and scales;
- 9. Female subjects who are positive in pregnancy test or breast-feeding and who cannot take effective contraceptive measures or have a birth plan;
- 10. Severe allergy, non-allergic drug reaction or multi-drug allergy history;
- 11. Participated in other clinical trials within 3 months before screening visit;
- 12. Taking any health care products related to brain and brain improvement currently and failing to keep the promise to stop using the above products;
- 13. Other conditions are unsuitable for participating in this study according to the judgement of researchers.
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): NCT04213391
Contact: Qing-Qing tao, Ph.D | +08613777820430 | qingqingtao@zju.edu.cn |
China, Zhejiang | |
Second Affiliated Hospital,Zhejiang University School of Medicine | Recruiting |
Hangzhou, Zhejiang, China, 310009 | |
Contact: Zhi-Ying Wu, MD&PhD +86-571-87783569 zhiyingwu@zju.edu.cn |
Responsible Party: | Second Affiliated Hospital, School of Medicine, Zhejiang University |
ClinicalTrials.gov Identifier: | NCT04213391 |
Other Study ID Numbers: |
Wulab-AD sulforaphane |
First Posted: | December 30, 2019 Key Record Dates |
Last Update Posted: | May 12, 2020 |
Last Verified: | May 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases |
Neurocognitive Disorders Mental Disorders Sulforaphane Anticarcinogenic Agents Protective Agents Physiological Effects of Drugs Antineoplastic Agents |