Clinical trial of Sailuotong (SLT) for Vascular Dementia or Alzheimer's Disease with evidence of cerebrovascular disease
A Multicentre, Randomised, Double-Blind, Placebo Controlled Trial to Evaluate the Effectiveness and Safety of Sailuotong (SLT), a Standardised Herbal Medicine Formula in Patients with Vascular Dementia and Alzheimer's Disease with Cerebrovascular Disease
Australia Shineway Technology Pty Ltd
250 participants
Aug 1, 2016
Interventional
Conditions
Summary
Dementia is the leading cause of mental and physical disability in the elderly. Vascular dementia (VaD) that accounts for 15-20% of all dementia cases is a syndrome of acquired cognitive functional impairment with a complex pathophysiological basis. Viable pharmaceutical options are currently lacking. Herbal medicine has been used for the treatment of ageing-related disorders for more than 2000 years ago in ancient China. Combination therapies are complex mixtures are believed to be able to enhance therapeutic efficacy through synergistic and multi-target mechanisms and are ideal and may be relevant for disorders such as VaD that has multifactorial / multisystem pathophysiology components. Conventional pharmaceutical techniques have been used to develop a novel, standardised herbal formulation, Sailuotong (SLT) targeting VaD. Data from pre-clinical studies have shown significant improvements in memory functions and in pathogenic biochemical parameters in various animal models. Appropriate safety of SLT has also been shown in acute and chronic toxicity and herb-drug interactions studies. We propose to undertake a rigorous phase III clinical trial of SLT in 250 patients with mild to moderate probable VaD or Alzheimer’s disease with cerebrovascular disease (AD+CVD). The aim of this 52-week randomised, multicentre, double-blind, placebo controlled trial is to: 1. Determine the efficacy of SLT on cognitive function and activities of daily living, and 2. Monitor the safety of SLT as a treatment for VaD or AD+CVD during a 52-week treatment period. The primary outcome measures include Vascular Dementia Assessment Scale cognitive subscale (VaDAS-cog) and Alzheimer’s Disease Co-operative Study Activities of Daily Living Inventory (ADCS-ADL). In addition, there are six secondary outcome measures including: The Clinician’s Interview Based Impression of Change-plus (CIBIC-plus), CLOX, EXIT-25, Quality of life, Neuropsychiatric Inventory-Clinician rating scale (NPI-C), and Functional MRI Assessment in a subset group. Liver and renal function and routine haematological tests will be conducted regularly during the trial. All adverse events will be recorded at each visit, including those suspected to be related to the treatment and any worsening of symptoms will be closely monitored.
Eligibility
Inclusion Criteria8
- 40-85* years old;
- 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;
- An MMSE score between 10 - 24 for the diagnosis of mild to moderate dementia;
- Absence of severe depression (Geriatric Depression Scale 15-item version, total score <=11);
- 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
- 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;
- 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;
- If female, has no intention to become pregnant during the study.
Exclusion Criteria10
- Have other types of dementia, and/or severe form of delirium, depression, schizophrenia, acute illness or poorly controlled chronic diseases
- If receiving any of the following drugs: donepezil, rivastigmine, galantamine, memantine, huperzine, have been on a stable dose for six months
- Have a history of severe forms of peptic ulcers, diabetes with complications, pulmonary disorders, renal and/or hepatic disorders
- 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
- Have severe dysphasia, mental retardation and/or life expectancy < 6 months
- Are allergic to more than 2 medications or at least 1 ingredient of SLT
- Are pregnant or lactating women
- Currently consuming any ingredients in the SLT formula including ginseng, ginkgo and saffron,
- Are participating in another clinical trial
- Have a stroke in the 3 months before screening
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Interventions
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.
Locations(9)
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ACTRN12616000057482