None listed
Conditions
Brief summary
This study examines the effect of curcumin taken orally, within a broader study investigating curcumin in the prevention of Alzheimer's disease. Participants will be allocated to either, no treatment or curcumin, for a period of 3-6 months. At the beginning and conclusion of the study, they will be required to undertake a brief cognitive assessment, answer lifestyle questions and donate blood. A once only mouth swab will also be taken. The intention of the study is to measure the influence of curcumin on the expression of inflammatory genetic markers, to examine if it is useful in reducing inflammation, by measuring associated proteins in the blood. The influence of curcumin on existing lifestyle patterns including sleep, activity levels and nutrition will also be examined through questionnaires at the end of the study.
Interventions
Arm 1: Healthy older people (n=12) will consume oral curcumin in capsule formulation, 1.5mg daily (x 3 divided doses) for a period of 3 or 6 months (optional extension by participant).
Arm 2: Mild Cognitive Impairment (n=12) will consume oral curcumin, in capsule formulation 1.5mg daily (x 3 divided doses) for a period of 3 or 6 months (optional extension by participant).
Adherence will be assessed by a capsule count at the 3 month TP and again at 6 months (if the optional extension has been e
Arm 1: Healthy older people (n=12) will consume oral curcumin in capsule formulation, 1.5mg daily (x 3 divided doses) for a period of 3 or 6 months (optional extension by participant). Arm 2: Mild Cognitive Impairment (n=12) will consume oral curcumin, in capsule formulation 1.5mg daily (x 3 divided doses) for a period of 3 or 6 months (optional extension by participant). Adherence will be assessed by a capsule count at the 3 month TP and again at 6 months (if the optional extension has been elected). Monthly phone calls will be made to the participant to monitor self-reported compliance.
Sponsors
McCusker Alzheimers Research Foundation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
65 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
Arm 1: Healthy Volunteers 1. Age 65-90 years, with general good health. 2. No significant history of cerebral vascular disease, such as a stroke, within the last 5 years. 3. Living in independent living units, or similar accommodation 4. English speaker, with adequate vision and hearing to enable testing 5. Normal general cognitive function, as determined by a Montreal Cognitive Assessment (MoCA) score, greater than or equal to 26. 6. No change in ADLs as determined by a clinical interview, and confirmed by an informant using the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) Arm 2: Mild Cognitive Impairment Volunteers 1-4, as listed above 5. Impairment in one or more cognitive domains including memory, executive function, attention, language, and visuospatial skills 6. A MoCa score of between 25-18 (age and education stratified) as agreed based on a clinical panel review. 7. Preservation of independence in functional abilities.
Exclusion criteria
1. Diagnosis of dementia based on the revised NIA/AA criteria 2. MoCA score of less than or equal to 17 3. Prior history of stroke within the last 5 years 4. Significant psychiatric disorder, including schizophrenia or bipolar disorder 5. History of alcohol or drug abuse / dependence within 2 years of screening 6. Uncontrolled, clinical or subclinical depression as evidenced by a score of greater or equal to 4 on the Geriatric Depression scale. 7. Uncontrolled hypertension (systolic BP >170; diastolic BP > 100) 8. Gastro-intestinal symptoms or conditions that are considered contra-indicated in the use of curcumin e.g. obstruction of the biliary tract
Outcome results
None listed