Effects of Sulforaphane in Patients With Prodromal to Mild Alzheimer's Disease

This is an interventional treatment trial for Alzheimer Disease Read More

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.