The effects of Solid Lipid Curcumin Particle Preparation (Longvida) on memory and cognition in adults with mild cognitive impairment
- Conditions
- Mild Cognitive ImpairmentNeurological - Other neurological disordersAlternative and Complementary Medicine - Herbal remedies
- Registration Number
- ACTRN12623000225617
- Lead Sponsor
- Clinical Research Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score[ Day 0 and week 12 (primary endpoint) post-intervention commencement];Montreal Cognitive Assessment (MoCA) total score[ Day 0 and week 12 (primary endpoint) post-intervention commencement]
- Secondary Outcome Measures
Name Time Method Change in blood concentrations of brain-derived neurotrophic factor (BDNF)[ Day 0 and week 12 post-intervention commencement];Change in blood concentrations of amyloid beta<br>[ Day 0 and week 12 post-intervention commencement];Changes in blood liver function profile (safety measure)[ Day 0 and week 12 post-intervention commencement];Changes in renal function blood test (safety measure)[ Day 0 and week 12 post-intervention commencement];Changes in full blood count (safety measure)[ Day 0 and week 12 post-intervention commencement]