Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000225617
Ethics application status
Approved
Date submitted
20/02/2023
Date registered
2/03/2023
Date last updated
28/01/2024
Date data sharing statement initially provided
2/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of Solid Lipid Curcumin Particle Preparation (Longvida) on memory and cognition in adults with mild cognitive impairment
Scientific title
The effects of Solid Lipid Curcumin Particle Preparation (Longvida) on memory and cognition in adults with mild cognitive impairment: a randomised, double-blind, placebo-controlled study
Secondary ID [1] 309043 0
None
Universal Trial Number (UTN)
U1111-1288-6984
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 329095 0
Condition category
Condition code
Neurological 326070 326070 0 0
Other neurological disorders
Alternative and Complementary Medicine 326071 326071 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 325486 0
Treatment: Other
Comparator / control treatment
A matching placebo (microcellulose capsules) in terms of taste and appearance and containing all ingredients except the active ingredient (Curcumin extract)
Control group
Placebo

Outcomes
Primary outcome [1] 333933 0
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score
Timepoint [1] 333933 0
Day 0 and week 12 (primary endpoint) post-intervention commencement
Primary outcome [2] 333934 0
Montreal Cognitive Assessment (MoCA) total score
Timepoint [2] 333934 0
Day 0 and week 12 (primary endpoint) post-intervention commencement
Secondary outcome [1] 418774 0
Change in blood concentrations of brain-derived neurotrophic factor (BDNF)
Timepoint [1] 418774 0
Day 0 and week 12 post-intervention commencement
Secondary outcome [2] 418775 0
Change in blood concentrations of amyloid beta
Timepoint [2] 418775 0
Day 0 and week 12 post-intervention commencement
Secondary outcome [3] 418777 0
Changes in blood liver function profile (safety measure)
Timepoint [3] 418777 0
Day 0 and week 12 post-intervention commencement
Secondary outcome [4] 418778 0
Changes in renal function blood test (safety measure)
Timepoint [4] 418778 0
Day 0 and week 12 post-intervention commencement
Secondary outcome [5] 418779 0
Changes in full blood count (safety measure)
Timepoint [5] 418779 0
Day 0 and week 12 post-intervention commencement

Eligibility
Key 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
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Permuted block randomisation using a randomisation table created by computer software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An a priori power analysis was undertaken to estimate the required sample size (based on a single outcome variable). In a meta-analysis based on the results of 4 studies investigating the effects of curcumin in healthy older-age adults on overall cognitive function, an effect size of 0.740 was identified. However, as this study is conducted on adults with MCI, a more conservative effect size of 0.6 is predicted. Assuming a power of 80% and a type one error rate (alpha) of 5%, the number of participants required per group to find an effect on the ADAS-Cog score was estimated as 36. Assuming a 10% dropout rate, it is planned to recruit 40 participants per group (80 participants in total), which is hypothesised to give suitable power to find an effect compared to the placebo, even after dropouts

Data will be analysed from weeks 0 to 12 using Generalised Linear Mixed Models (GLMM) with intervention effects assessed by intervention group (placebo and curcumin) x time interaction. Time points considered for each measure are weeks 0 and 12. Random intercepts will be utilised in each model, and covariates age, sex, and BMI.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/03/2023
Actual
27/03/2023
Date of last participant enrolment
Anticipated
2/10/2023
Actual
6/10/2023
Date of last data collection
Anticipated
1/01/2024
Actual
22/12/2023
Sample size
Target
80
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 313247 0
Commercial sector/Industry
Name [1] 313247 0
Verdure Sciences Pty Ltd
Country [1] 313247 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
38 Arnisdale Rd Duncraig WA 6023
Country
Australia
Secondary sponsor category [1] 314976 0
None
Name [1] 314976 0
Address [1] 314976 0
Country [1] 314976 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312478 0
National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
Ethics committee address [1] 312478 0
Ethics committee country [1] 312478 0
Australia
Date submitted for ethics approval [1] 312478 0
18/01/2023
Approval date [1] 312478 0
21/02/2023
Ethics approval number [1] 312478 0
0121E_2023

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124806 0
Dr Adrian Lopresti
Address 124806 0
Clinical Research Australia 38 Arnisdale Rd Duncraig WA 6023
Country 124806 0
Australia
Phone 124806 0
+61 08 94487376
Fax 124806 0
Email 124806 0
[email protected]
Contact person for public queries
Name 124807 0
Adrian Lopresti
Address 124807 0
Clinical Research Australia 38 Arnisdale Rd Duncraig WA 6023
Country 124807 0
Australia
Phone 124807 0
+61 08 94487376
Fax 124807 0
Email 124807 0
[email protected]
Contact person for scientific queries
Name 124808 0
Adrian Lopresti
Address 124808 0
Clinical Research Australia 38 Arnisdale Rd Duncraig WA 6023
Country 124808 0
Australia
Phone 124808 0
+61 08 94487376
Fax 124808 0
Email 124808 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Case-by-case basis at the discretion of Primary Sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?
• Individual participant data underlying published results

What types of analyses could be done with individual participant data?
• for IPD meta-analyses

When can requests for individual participant data be made (start and end dates)?
From:
Beginning 3 months and ending 5 years following main results publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.