The epigenetic effect of curcumin as measured in the blood and seen within lifestyle, for the prevention of Alzheimer's disease.

Phase 2

Completed

• Conditions: Alzheimers disease; Neurological - Alzheimer's disease

• Registration Number: ACTRN12614001024639
• Lead Sponsor: McCusker Alzheimers Research Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the APOE genotype specific effects of BCM-95 on the expression of inflammatory genes through associated blood biomarkers[Baseline (0) & 3 month, and an optional 6 month. <br>(Optional extension of participation to 6 months).];The epigenetic effect of curcumin on inflammatory gene methylation as measured through blood based cytokines, interleukins and other macrophage inflammatory proteins within healthy and MCI groups.[Baseline (0) & 3 month, and an optional 6 month. <br>(Optional extension of participation to 6 months).]