Clinical trial of Sailuotong (SLT) for Vascular Dementia or Alzheimer's Disease with evidence of cerebrovascular disease

Inclusion criteria: 1. >=40 years old; 2. Outpatients diagnosed with either probable VaD as defined by the National Institute of 3. Neurological Disorders and Stroke (NINCDS) and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences (AIREN) or possible Alzheimer’s Disease as defined by the National Institute of Neurological and Communication Disorders and Stroke (NINCDS)‐Alzheimer's Disease and Related Disorders Association (ADRDA) with significant neuroimaging (CT or MRI) evidence of cerebrovascular disease, at least 3 months prior to screening; 3.. An MMSE score between 10 ‐ 24 for the diagnosis of mild to moderate dementia; 4. Absence of severe depression (Geriatric Depression Scale 15‐item version, total score <=11); 5. Stable or controlled by optimal medication over at least 3 months for, (if present) hypertension, diabetes, cardiac disease or stroke, or if on hypnotics and sedatives for more than 3 months prior to inclusion in the study ; 6. Agreement to take part in the study as evidenced by a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative if the subject is unable to provide consent), has been informed of all pertinent aspects of the study; 7. For patients who have a Study Partner/Carer, this Carer must be able to assist the subject comply with the study protocol. This requires the Study Partner/Carer to be in contact with the subject at least 2 days per week; 8. If female, has no intention to become pregnant during the study. Exclusion criteria: 1. Have other types of dementia, and/or severe form of delirium, depression, schizophrenia, acute illness or poorly controlled chronic diseases; 2. Receive administration of the following drugs/herbs including donepezil, rivastigmine, galantamine, memantine,, huperzine, and any ingredients in the SLT formula including ginseng, ginkgo and saffron.; 3. Have a history of severe forms of peptic ulcers, diabetes with complications, pulmonary disorders, renal and/or hepatic disorders; 4. Abnormal pathology test results: Cr > 1.5 times upper limit of normal (ULN); Alt, AST or ALP > 2 times ULN; PT > 3 second more than ULN; APTT > 10 seconds more than ULN; Plt < 100,000/mcL 5. Have severe dysphasia, mental retardation and/or life expectancy < 6 months; 6. Are allergic to more than 2 medications or at least 1 ingredient of SLT; 7. Are pregnant or lactating women. Vascular Dementia ;Alzheimer's Disease with Cerebrovascular Disease STL active compounds: Ginsenosides powder – 27.27 mg per capsule; ginkgo flavone glycosides–27.27 mg per capsule; crocins – 5.46 mg per capsule. Participants randomised to the active group will take 2 SLT capsules (60 mg/capsule) orally, twice daily for 52 weeks. Adherence to the protocol will be monitored by drug tablet return. The difference between SLT and the placebo groups in the changes between the Vascular Dementia Assessment Scale‐cognitive Subscale (VaDAS‐cog) scores from baseline;The difference between SLT and the placebo groups in the changes between the Alzheimer's Disease Cooperative Study‐activities of daily living (ADCS‐ADL) scores from baseline The difference between SLT and the placebo groups in the changes in neuropsychiatric symptoms (comprising delusions, hallucinations, depression/dysphoria, anxiety, agitation/aggression, euphoria, dis‐inhibition, irritability/lability, apathy, aberrant motor activity and, night‐time behaviour disturbances) in the changes in the Neuropsychiatric Inventory‐Clinician rating scale (NPI‐C) scores from Baseline. ;The difference between SLT and the placebo group in the changes between the Clinician’s Interview Based Impression of Change‐plus (CIBIC‐plus) scores from baseline ;The differences between the SLT and placebo group in the changes between the additional executive function tests including CLOX and EXIT‐25 scores from baseline ;The difference between SLT and the placebo group in the changes between the Cornell Scale of Depression in D mentia scores from Baseline ;The difference between SLT and the placebo group in the changes in the dementia quality of life (DEMQOL) scores from baseline;The difference between SLT and the placebo groups in the changes between changes in cerebral blood flow and volumes as determined by MRI from Baseline ;Safety ‐ 'Liver and renal function and routine haematological tests (FBC, coagulation, platelet function) will be conducted at each visit and any AEs will be reported. Although serious adverse events (SAEs) are not anticipated for this trial, SAE procedures will be followed in these circumstances.