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

Phase 3

Suspended

• Conditions: Vascular Dementia; Alzheimer's Disease with Cerebrovascular Disease; Alternative and Complementary Medicine - Herbal remedies; Neurological - Dementias; Neurological - Alzheimer's disease

• Registration Number: ACTRN12616000057482
• Lead Sponsor: Australia Shineway Technology Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-20
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. 40-85* 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;
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
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. Participants must also have a Study Partner/Carer, that can 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. If receiving any of the following drugs: donepezil, rivastigmine, galantamine, memantine, huperzine, have been on a stable dose for six months
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
8. Currently consuming any ingredients in the SLT formula including ginseng, ginkgo and saffron,
9. Are participating in another clinical trial
10. Have a stroke in the 3 months before screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified