None listed
Conditions
Brief summary
The earlier KARVIAH Project recruited (n= 105) participants who took either curcumin or placebo orally for a period of 12 months. Participants were between the ages of 65-90 years living in retirement living accommodation or similar. Each participant undertook a health review, including general demographics, age, education, health and medication history and vital signs. During the study a comprehensive cognitive assessment was taken, blood drawn, lifestyle questionnaires completed (exercise, nutrition and sleep quality), as well as cerebral Magnetic Resonance Imaging (MRI); amyloid beta positron emission tomography (Aß- PET) and fluorodeoxyglucose (FDG-PET), The KARVIAH_XTND study will investigate biomarkers and longitudinal quality of life measure post curcumin intervention, as well as non-modifiable and modifiable lifestyle and health risk factors which may influence cognitive function.
Interventions
The previous KARVIAH_MK002 study recruited cognitively healthy participants aged 65-90 yrs of age to participate in a 12 month intervention of curcumin 1500mg daily (500mg capsules taken 3 times per day) or placebo (identical non-active ingredient capsules) for a period of 12 months.
The KARVIAH_XTND study is a non-intervention study will investigate the current physical and cognitive health of participants based on cognitive and memory function, physical assessment, blood, urine, lifestyle, a
The previous KARVIAH_MK002 study recruited cognitively healthy participants aged 65-90 yrs of age to participate in a 12 month intervention of curcumin 1500mg daily (500mg capsules taken 3 times per day) or placebo (identical non-active ingredient capsules) for a period of 12 months. The KARVIAH_XTND study is a non-intervention study will investigate the current physical and cognitive health of participants based on cognitive and memory function, physical assessment, blood, urine, lifestyle, and cerebral PET amyloid imaging. Recruitment will include participants previously recruited for the KARVIAH study in addition to new participants. The KARVIAH_XTND will undertake cognitive assessments, collect blood and urine samples, and undertake health and lifestyle review, vital signs, gait and grip strength, in addition to brain (PET amyloid-beta) imaging. Measures used for memory and cognitive function will include: MoCA, Geriatric Depression Scale (GDS), Rey Auditory Verbal Assessment Long term memory (RAVALT), Clinical Dementia Rating (CDR) (sum of boxes), Depression, Anxiety and Stress (DASS), Wechsler Test of Adult Reading (WTAR); Mini-mental state examination (MMSE); Category fluency; Controlled Oral Word Association; Boston Naming Test; Digit Span test; Digit Symbol test. - all conducted annually. Questionnaires: Assessment of Memory Complaint Questionnaire (MAC-Q) - Annual Neuroticism-Extroversion-Openness Five Factor Inventory Personality Inventory - Once only Prospective and Retrospective Memory Questionnaire (PRMQ) - Annual Subjective Cognitive Impairement Questionnaire - Annual Pittsburgh Quality Sleep Index - Annual Community Healthy Activities Model Program for seniors - Annual Food Frequency Questionnaire - Annual Physical health will be assessed using: Mini Sarcopaenia Risk assessment - Annual SF 36- Annual Informant questionnaire (optional) Alzheimer's Disease Cooperative Study - Activities of Daily living - annual Dysexecutive Questionnaire - annual Informant Questionnaires of Cognitive Decline in the Elderly - annual All tests will be undertaken annually for a period of 3 years Post intervention (Kx0, 12, 24, 36 months), except for the PET amyloid brain image which is scheduled at Kx0 and the end of study. The PET image will measure the Standard Uptake Value Ratio of 18F-Florbetaben to assess cerebral amyloid-beta load. Some information including medical health updates, and questionnaires can if preferred by the participant, conducted over the telephone to reduce the onsite length of visit, however, the cognitive testing, blood draw, vital signs and brain imaging, will require a face to face appointment. Cognitive assessments are conducted by experienced raters, trained and supervised by a clinical neuropsychologist on the study. Clinical assessment and governance is provided by the PI or nominated medical Sub-I. The annual visit is expected to take up to 4 hours, with the all assessments undertaken (excluding brain imaging) at the KaRa Institute of Neurological Diseases, 35-41 Waterloo Road, Macquarie Park, 2113, NSW. Imaging procedures are conducted at the Macquarie Health Imaging Facility, Macquarie University, Macquarie Park. Data collected in this study will be compared with previous data (blood, cognitive, lifestyle and PET amyloid imaging from the earlier McCusker KARVIAH study (completed 2016)
Sponsors
KaRa Institute of Neurological Diseases Pty Ltd
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
The Previous participant within the KARVIAH study (ACTRN 12613000681752) will be invited however, new participants will also be recruited matching the following criteria. 1. Minimum of 65 years of age 2. Generally healthy or medically stable and willing to undertake the visit schedule 3. Living in independent living units, or similar accommodation, 4.. English speaker, 5. Adequate vision and hearing 6. Able to complete cognitive testing 7. Willing to undertake a blood test 8. Willing to undertake an MRI/PET brain image (exclusion of this procedure is at the discretion of the PI)
Exclusion criteria
1. Presence of acute functional psychiatric disorder including; lifetime history of schizophrenia or bipolar disorder, 2. Clinically significant abnormalities in the blood, which require clinical intervention 3. Prior medical history of a stroke within the last 2 years, 4. History of alcohol or drug abuse / dependence within 2 years of screening, 5. Hearing or visual impairments sufficient to hinder cognitive testing, 6. Any circumstance whereby the PI/Sub-Investigator feels that participation was not in the best interest of the participant, or the participant was unable to meet the study visit requirements.
Outcome results
None listed