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Trial record 1 of 1 for:    NCT01001637
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Efficacy and Safety of Curcumin Formulation in Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Pharmanza Herbal Pvt Ltd
Verdure Sciences
University of California, Los Angeles
Information provided by:
Jaslok Hospital and Research Centre

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Dietary Supplement: Curcumin Formulation Dietary Supplement: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Active Comparator: curcumin Dietary Supplement: Curcumin Formulation
2000mg or 3000mg daily BID
Other Name: Longvida

Placebo Comparator: Placebo Dietary Supplement: Placebo

Primary Outcome Measures :
  1. To determine if curcumin formulation affects mental capacity in Alzheimer's patients based on mental exams [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. To determine if curcumin formulation changes blood concentrations of amyloid-beta [ Time Frame: 60 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01001637

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Contact: Fali Poncha, MD 9820711140
Contact: Nitin Kochar, MD 9819702151

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Jaslok Hospital and research centre Recruiting
Mumbai, Maharashtra, India, 400026
Contact: Fali Poncha, MD, DM Neuro    9820711140   
Contact: Nitin Kochar, MD    9819702151   
Principal Investigator: Fali Poncha, DM neuro         
Sponsors and Collaborators
Jaslok Hospital and Research Centre
Pharmanza Herbal Pvt Ltd
Verdure Sciences
University of California, Los Angeles
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Study Director: Fali Poncha, DM neuro Jaslok Hospital and Research Centre
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Responsible Party: Dr Fali Poncha, Jaslok Hospital and Research centre Identifier: NCT01001637    
Other Study ID Numbers: Longvida
First Posted: October 26, 2009    Key Record Dates
Last Update Posted: October 26, 2009
Last Verified: October 2009
Keywords provided by Jaslok Hospital and Research Centre:
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action