Efficacy and Safety of Curcumin Formulation in Alzheimer's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Jaslok Hospital and Research Centre.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Pharmanza Herbal Pvt Ltd
Verdure Sciences
University of California, Los Angeles
Information provided by:
Jaslok Hospital and Research Centre
ClinicalTrials.gov Identifier:
NCT01001637
First received: October 15, 2009
Last updated: October 23, 2009
Last verified: October 2009

October 15, 2009
October 23, 2009
October 2009
June 2010   (final data collection date for primary outcome measure)
To determine if curcumin formulation affects mental capacity in Alzheimer's patients based on mental exams [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01001637 on ClinicalTrials.gov Archive Site
To determine if curcumin formulation changes blood concentrations of amyloid-beta [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Curcumin Formulation in Alzheimer's Disease
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Alzheimer Disease
  • Dietary Supplement: Curcumin Formulation
    2000mg or 3000mg daily BID
    Other Name: Longvida
  • Dietary Supplement: Placebo
    Placebo
  • Active Comparator: curcumin
    Intervention: Dietary Supplement: Curcumin Formulation
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
26
November 2010
June 2010   (final data collection date for primary outcome measure)

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).
Both
50 Years to 80 Years
No
Contact: Fali Poncha, MD 9820711140 fali@rediffmail.com
Contact: Nitin Kochar, MD 9819702151 nitinkochar@gmail.com
India
 
NCT01001637
Longvida, 919820711140
No
Dr Fali Poncha, Jaslok Hospital and Research centre
Jaslok Hospital and Research Centre
  • Pharmanza Herbal Pvt Ltd
  • Verdure Sciences
  • University of California, Los Angeles
Study Director: Fali Poncha, DM neuro Jaslok Hospital and Research Centre
Jaslok Hospital and Research Centre
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP