Back to resultsEfficacy and Safety of Curcumin Formulation in Alzheimer's Disease
Primary Purpose
Alzheimer Disease
Status
Terminated
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Curcumin Formulation
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring curcumin, alzheimer's, longVida, dementia
Eligibility Criteria
Inclusion Criteria:
- Male or Female age ≥ 50.
- Diagnosed with probable AD using NINDS-ADRDA research criteria. MMSE score ≥5 and ≤20.
- No history of significant psychiatric or non-AD neurological disease.
- An available caregiver to monitor and administer medication and to accompany the subject to every clinical visit.
- On stable doses of concomitant medications for at least one month prior to starting study medication.
Exclusion Criteria:
- Current or recent major psychiatric illness that meets DSM-IV criteria (i.e. bipolar disorder, schizophrenia).
- Significant uncontrolled systemic illness (i.e. chronic renal failure, chronic liver disease, poorly controlled diabetes, or poorly controlled congestive heart failure).
- Recent history of gastrointestinal bleeding or ulceration.
- Alcoholism or substance abuse within the past year per DSM-IV criteria.
- Familial, autosomal dominant Alzheimer's disease due to a mutation in a known gene (Presenilin-1, Presenilin-2, or Amyloid Precursor Protein).
Sites / Locations
- Jaslok Hospital and research centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
curcumin
placebo
Arm Description
Outcomes
Primary Outcome Measures
To determine if curcumin formulation affects mental capacity in Alzheimer's patients based on mental exams
Secondary Outcome Measures
To determine if curcumin formulation changes blood concentrations of amyloid-beta
Full Information
NCT ID
NCT01001637
First Posted
October 15, 2009
Last Updated
September 26, 2023
Sponsor
Jaslok Hospital and Research Centre
Collaborators
Pharmanza Herbal Pvt Ltd, Verdure Sciences, University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT01001637
Brief Title
Efficacy and Safety of Curcumin Formulation in Alzheimer's Disease
Official Title
Phase II Study of Curcumin Formulation (Longvida) or Placebo on Plasma Biomarkers and Mental State in Moderate to Severe Alzheimer's Disease or Normal Cognition
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
lack of support
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jaslok Hospital and Research Centre
Collaborators
Pharmanza Herbal Pvt Ltd, Verdure Sciences, University of California, Los Angeles
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Curcumin is shown to impact several different pathways of neuroprotection, however clinical trials have not shown positive results, due to the poor bioavailability of curcumin. This study is designed to determine efficacy and safety of high-bioavailability curcumin formulation (Longvida) in subjects with Alzheimer's disease.
Detailed Description
Curcumin is a polyphenolic molecule that comprises approximately 3-5% of turmeric (Curcuma longa) root, giving the spice its characteristic yellow color. Because of its anti-inflammatory, anti-amyloid, and antioxidant properties, curcumin has shown positive effects in animal models of Alzheimer's disease (AD). However, a six month human study was conducted with unformulated curcumin showing insignificant trends, due to limited bioavailability and brain permeability of unformulated curcumin. In animal models of AD, oral dosing of solid-lipid curcumin particle (SLCP or Longvida) significantly reduced memory deficit and impacted biomarkers better than unformulated curcumin. This study is to determine the potential efficacy and safety of highly absorbed SLCP curcumin in subjects with AD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
curcumin, alzheimer's, longVida, dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
curcumin
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Curcumin Formulation
Other Intervention Name(s)
Longvida
Intervention Description
2000mg or 3000mg daily BID
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
To determine if curcumin formulation affects mental capacity in Alzheimer's patients based on mental exams
Time Frame
60 days
Secondary Outcome Measure Information:
Title
To determine if curcumin formulation changes blood concentrations of amyloid-beta
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or Female age ≥ 50.
Diagnosed with probable AD using NINDS-ADRDA research criteria. MMSE score ≥5 and ≤20.
No history of significant psychiatric or non-AD neurological disease.
An available caregiver to monitor and administer medication and to accompany the subject to every clinical visit.
On stable doses of concomitant medications for at least one month prior to starting study medication.
Exclusion Criteria:
Current or recent major psychiatric illness that meets DSM-IV criteria (i.e. bipolar disorder, schizophrenia).
Significant uncontrolled systemic illness (i.e. chronic renal failure, chronic liver disease, poorly controlled diabetes, or poorly controlled congestive heart failure).
Recent history of gastrointestinal bleeding or ulceration.
Alcoholism or substance abuse within the past year per DSM-IV criteria.
Familial, autosomal dominant Alzheimer's disease due to a mutation in a known gene (Presenilin-1, Presenilin-2, or Amyloid Precursor Protein).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fali Poncha, DM neuro
Organizational Affiliation
Jaslok Hospital and Research Centre
Official's Role
Study Director
Facility Information:
Facility Name
Jaslok Hospital and research centre
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400026
Country
India
12. IPD Sharing Statement
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Efficacy and Safety of Curcumin Formulation in Alzheimer's Disease
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