Authors
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Swinburne University of Technology, Centre for Human Psychopharmacology -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2012
INTERVENTION: In the first stage of the study optimised curcumin (400mg) will be taken by 30 individuals (20 cognitively healthy 10 with evidence of cognitive decline) and placebo will be taken for 30 individuals (20 cognitively healthy 10 with evidence of cognitive decline), for a four week period (28 days). A total of 4 treatment groups (cognitive status x treatment) will be included. All treatments are to be taken as one oral capsule per day, with the first treatment administered during baseline testing session and final treatment administered during four‐week follow‐up testing session. A subset of 16 participants, with apparent cognitive decline, will also take part in Stage Two of the study in which treatment dose and duration will be increased (800mg curcumin once daily, for eight weeks) and effect of supplementation on cerebral blood flow will be examined. Stages One and Two will be separated by a wash out period of a minimum of one month. CONDITION: Cerebral Blood Flow (fMRI) Cognitive function Inflamation Mood, stress and fatigue Oxidative stress PRIMARY OUTCOME: Cognitive performance ‐ performance on the following Computerised Mental Performance Assessment System (COMPASS) tasks: immediate and delayed word recall, delay word recognition, delayed picture recognition, simple reaction time, choice reaction time, digit vigilance, rapid visual information processing (Bakan) task and Serial subtraction (3s and 7s) Mood and anxiety assessments: ; Chronic mood ‐ General Health Questionnaire, Chalder Fatigue Scale, Depression, Anxiety and Stress Scale (DASS) ; ; Acute/State Mood ‐ State‐Trait Anxiety Inventory (STAI) state scale, Bond‐Lader Visual Analogue Scales, stress and fatigue visual analogue mood scales. SECONDARY OUTCOME: Blood biomarkers: ; blood lipids (LDL, HDL, triglycerides, total cholesterol), ; C‐reactive protein (CRP), ; fibrinogen ; inflammatory cytokines IL1B and IL6 ; amyloid‐beta 40 and 42, ; telomere length, ; SIRT‐1 expression fMRI brain imaging and performance on rapid visual information processing and inspection time tasks completed during scan. INCLUSION CRITERIA: 1. Male or female. 2. Aged 65‐80 years. 3. Willing and able to provide written informed consent. 4. Understands and is willing and able to comply with all study procedures. 5. Free from history of stroke, other neurological conditions (e.g. Parkinsons, epilepsy), depression, psychiatric disorders, low base line intellect, alcohol abuse past / present. 6. Cognitively healthy participants must be free from any form of cognitive impairment. For the cognitively declined particpants, participants must have objective memory impairment for age and education level. 7. Free from dementia. 8. English speaking. 9. Must have normal or corrected vision. 10. Free from other medical conditions which may affect ability to participate in the study 11. Participants taking part in study Stage Two must be right handed
Epistemonikos ID: 4e551a39f29cc1aef55c925a6c8cb1b05b999584
First added on: Aug 25, 2024