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Trial record 50 of 167 for:    curcumin

Efficacy and Safety of Curcumin Formulation in Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT01001637
Recruitment Status : Unknown
Verified October 2009 by Jaslok Hospital and Research Centre.
Recruitment status was:  Recruiting
First Posted : October 26, 2009
Last Update Posted : October 26, 2009
Sponsor:
Collaborators:
Pharmanza Herbal Pvt Ltd
Verdure Sciences
University of California, Los Angeles
Information provided by:
Jaslok Hospital and Research Centre

Tracking Information
First Submitted Date  ICMJE October 15, 2009
First Posted Date  ICMJE October 26, 2009
Last Update Posted Date October 26, 2009
Study Start Date  ICMJE October 2009
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2009)
To determine if curcumin formulation affects mental capacity in Alzheimer's patients based on mental exams [ Time Frame: 60 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2009)
To determine if curcumin formulation changes blood concentrations of amyloid-beta [ Time Frame: 60 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Curcumin Formulation in Alzheimer's Disease
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Dietary Supplement: Curcumin Formulation
    2000mg or 3000mg daily BID
    Other Name: Longvida
  • Dietary Supplement: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: curcumin
    Intervention: Dietary Supplement: Curcumin Formulation
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 23, 2009)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2010
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01001637
Other Study ID Numbers  ICMJE Longvida
919820711140
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Fali Poncha, Jaslok Hospital and Research centre
Study Sponsor  ICMJE Jaslok Hospital and Research Centre
Collaborators  ICMJE
  • Pharmanza Herbal Pvt Ltd
  • Verdure Sciences
  • University of California, Los Angeles
Investigators  ICMJE
Study Director: Fali Poncha, DM neuro Jaslok Hospital and Research Centre
PRS Account Jaslok Hospital and Research Centre
Verification Date October 2009

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