None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 80 adults aged 50 to 85 years with mild cognitive impairment will be randomly assigned to receive capsules containing either a curcumin extract (Longvida, 400 mg daily) or a placebo for 12 weeks. Changes in cognitive performance will be assessed at baseline and week 12 by administering the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) and the Montreal Cognitive Assessment (MoCA). Moreover, to help understand how curcumin works to improve cognitive function, changes in blood concentrations of Brain-derived neurotrophic factor (BDNF) and Amyloid beta (Aß) will be measured over time.
Interventions
Curcumin extract (Longvida) (1 capsule taken orally, once daily in the morning or evening with or without food, delivering 400 mg a day for 12 weeks). Adherence to capsule intake will be measured by capsule return at week 12.
Sponsors
Clinical Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Male and females 2. Age 50 to 85 years 3. Mild cognitive impairment as determined by: (1) Montreal Cognitive Assessment (MoCA) blind score during the telephone assessment between 13 and 19, and (2) MoCA score between 19 and 25 at visit 1 4. BMI between 18 and 35 kg/m2 5. Non-smoker 6. No plan to commence new treatments over the study period 7. Understand, willing and able to comply with all study procedures 8. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial. 9. Normal or corrected vision with no colour blindness 10. Free from medical conditions which may affect ability to participate in the study
Exclusion criteria
1. Diagnosis of dementia based on the revised National Institute on Aging-Alzheimer’s Association (NIA/AA) criteria 2. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, diabetes, gallbladder disease, autoimmune disease, endocrine disease, or cancer/ malignancy 3. Abnormal findings on blood test as determined by (1) Aspartate Transferase or Alanine Transaminase more than 3 times the upper limit of normal, (2) Hemoglobin less than or equal to 8 g/Dl or platelet less than 100,000/mm3, or (3) adults with acute or chronic renal failure whose serum creatinine is 3 times the upper limit of normal or who requires dialysis 4. Diagnosis of a psychiatric disease (other than mild-to-moderate depression or anxiety) and/or neurological condition/ disease (e.g., Parkinson’s, Alzheimer’s disease) 5. History of paralysis, stroke or seizures or head injury (with loss of consciousness) within 6 months of study commencement. 6. Severe hearing and vision impairment 7. Regular medication intake including but not limited to anticholinergics, anti-epileptics, acetylcholinesterase inhibitors, antipsychotics, or opioids. 8. Change in medication in the last 3 months or expectation to change during the study duration 9. In the last 3 months, commenced or changed dose of nutritional and/or herbal supplements that may impact on treatment outcome 10. Current or 12-month history of illicit drug abuse 11. Alcohol intake greater than 14 standard drinks per week 12. Pregnant women, women who are breastfeeding or women who intended to fall pregnant. 13. Any significant surgeries over the last year 14. Planned major lifestyle change in the next 3 months 15. Hypersensitivity to curcumin, turmeric, or other spices
Outcome results
None listed