None listed
Conditions
Brief summary
Mild cognitive impairment (MCI) causes a slight but noticeable decline in cognitive abilities, and is conceptualised as a transitional prodromal stage between healthy ageing and dementia. It is estimated that up to 35 % of Australians aged 70 and older have MCI, and 15 % of those individuals will go on to develop dementia within a year. Currently, there are no treatment options for MCI, and anti-dementia pharmaceuticals are largely ineffective as they act on a single therapeutic target, which does not address the multifaceted pathophysiology of MCI. The project aims to evaluate the mechanisms of action and test the efficacy and safety of a novel multi-target treatment for MCI due to Alzheimer's disease: Sailuotong (SLT), a standardised herbal medicine formula. SLT capitalises on the multi-system approach of Chinese herbal medicine, containing multiple standardised active components including Panax ginseng, Ginkgo biloba, and Crocus sativus (saffron), and has already shown promise as a potential treatment for vascular dementia. This project will involve a 12 week randomised, double-blind, placebo-controlled trial of 180 mg/day SLT for cognitive function in people with MCI due to Alzheimer's disease. The co-primary outcome measures are episodic memory as measured by Logical Memory Story A - Delayed Recall, perceptual processing speed as measured by Digit Symbol Coding, and executive function as measured by the D-KEFS (Delis-Kaplan Executive Function System) Trail Making Test Condition 4 and the Rey Complex Figure Test (RCFT). Secondary outcome measures include: the Montreal Cognitive Assessment (MoCA), Block Design, Digit Span, Logical Memory Story A - Immediate Recall, D-KEFS Trail Making Test Condition 2, Rey Auditory Verbal Learning Test (RAVLT), Benton Visual Retention Test, 15-item Boston Naming Test, Semantic Fluency, the Controlled Oral Word Association Test, the Functional Activities Questionnaire (FAQ), Quality of Life in Alzheimer's Disease scale (QoL-AD), and the 21-item Depression, Anxiety, Stress Scale (DASS-21). We will also examine the mechanisms of action of SLT in people with MCI by assessing brain activity via electroencephalograph (EEG), autonomic activity via skin conductance and electrocardiograph (ECG), cerebral blood flow via carotid artery ultrasound, and serum inflammatory markers including IL-6, IL-1beta, and TNF-alpha.
Interventions
12 weeks 180 mg/day (2 x 45 mg oral capsules each morning and night) SLT formula (81.84 mg ginsenosides, 81.84 mg total ginkgo flavone-glycosides, 16.36 mg crocins).
Each SLT capsule contains a 45 mg standardised mixture of 20.46 mg ginsenosides extracted from Panax ginseng, 20.46 mg total ginkgo flavone-glycosides extracted from Ginkgo biloba, and 4.09 mg crocins extracted from Crocus sativa.
Adherence will be assessed via medication diaries, and collecting any unused tablets and midpoint a
12 weeks 180 mg/day (2 x 45 mg oral capsules each morning and night) SLT formula (81.84 mg ginsenosides, 81.84 mg total ginkgo flavone-glycosides, 16.36 mg crocins). Each SLT capsule contains a 45 mg standardised mixture of 20.46 mg ginsenosides extracted from Panax ginseng, 20.46 mg total ginkgo flavone-glycosides extracted from Ginkgo biloba, and 4.09 mg crocins extracted from Crocus sativa. Adherence will be assessed via medication diaries, and collecting any unused tablets and midpoint and endpoint.
Sponsors
Western Sydney University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Greater than or equal to 60 years of age No diagnosis of dementia Confirmed diagnosis of MCI due to Alzheimer’s disease core clinical criteria according to the National Institute on Aging-Alzheimer’s Association (NIA-AA) working group guidelines (Albert et al., 2011) No severe depression by scoring less than or equal to 19 on the Geriatric Depression Scale (GDS) Agreement to take part in the study as evidenced by a personally signed and dated informed consent document Albert, M.S., et al., The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement, 2011. 7(3): p. 270-9.
Exclusion criteria
Less than 60 years of age Diagnosis of psychiatric disorder(s) including: dissociative disorder, obsessive-compulsive disorder, personality disorder, schizophrenia, bipolar disorder History of drug and alcohol dependence or substance-related disorders History of seizures Head trauma with loss of consciousness Left-handedness measured by scoring less than 0 on the Edinburgh Handedness Inventory Allergy to at least 1 ingredient of SLT (Ginkgo biloba, Panax ginseng, or Crocus sativus) Current use of supplements containing Ginkgo biloba, Panax ginseng, or Crocus sativus (8 week washout period required) History of several renal and hepatic disorders
Outcome results
None listed