None listed
Conditions
Brief summary
The study is designed to examine the lifestyle and health risk factors of participants in an older age group, living in retirement setting. Those most at risk of Alzheimer's disease (AD) will then be given curcumin /placebo to examine its abiltity to reduce or slow the risk of developing the AD.
Interventions
Participants will be aged 65-90 and the introduction of the Curcumin (Biocurcumax TM) will be titrated as follows:
500mg daily for 2/ wks, progressing to
500mg twice daily (1,000mg/daily) for 2 weeks, then
500mg three times daily, (1,500mg) onwards
The Curcumin is formulated into a capsule and is taken with a glass of water after meals.
The intervention will be for a period of 12 months in total.
Sponsors
McCusker Alzheimer's Research Foundation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
65 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
Age 65-90 years, with good health and no significant cerebral vascular disease Living in independent living units, or similar accommodation English speaker Adequate vision and hearing to enable testing Memory complaint as determined by MAC-Q, and preferably corroborated by an informant No objective memory impairment, based on cognitive test scores Normal general cognitive function as determined by a Montreal Cognitive Assessment (MoCA) score, greater than or equal to 26 during screening No significant functional impairments Intact ADL i.e. no or minimal impairment in activities of daily living (ADLs), as determined by a clinical interview
Exclusion criteria
Diagnosis of dementia based on the revised criteria from NIA/AA Montreal Cognitive Assessment (MoCA) score less than or equal to 17 Significant functional impairments/behavioural problems as indicated by the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) and the 36-Item Short Form Health Survey (SF-36) Presence of acute functional psychiatric disorder including; lifetime history of schizophrenia or bipolar disorder Prior medical history of stroke History of alcohol or drug abuse / dependence within 2 years of screening Depression, as indicated on the DASS Use of Warfarin, within 4 weeks of screening Current or previous bile duct obstruction, gallstones, and gastrointestinal disorder Contraindication to MRI, including, but not limited to those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant History of closed angle glaucoma, or related conditions, contraindicated for retinal scanning Uncontrolled hypertension (systolic BP > 170 or diastolic BP > 100) Any significant systemic illness or unstable medical condition that could lead to difficulty complying with the protocol including: history of myocardial infarction in the past year or unstable or severe cardiovascular disease including angina or congestive heart disease, chronic renal failure, chronic hepatic disease, severe pulmonary disease Clinically significant and unstable gastrointestinal disorder such as ulcer disease or a history of active or occult gastrointestinal bleeding within two years.
Outcome results
None listed