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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

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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

Study Description
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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.
Study Design
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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

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


Outcome Measures
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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 ]

Eligibility Criteria
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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
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).
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01001637


Contacts
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Contact: Fali Poncha, MD 9820711140 fali@rediffmail.com
Contact: Nitin Kochar, MD 9819702151 nitinkochar@gmail.com

Locations
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India
Jaslok Hospital and research centre Recruiting
Mumbai, Maharashtra, India, 400026
Contact: Fali Poncha, MD, DM Neuro    9820711140    fali@rediffmail.com   
Contact: Nitin Kochar, MD    9819702151    nitinkochar@gmail.com   
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
Investigators
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Study Director: Fali Poncha, DM neuro Jaslok Hospital and Research Centre
More Information
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Responsible Party: Dr Fali Poncha, Jaslok Hospital and Research centre
ClinicalTrials.gov Identifier: NCT01001637    
Other Study ID Numbers: Longvida
919820711140
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:
curcumin
alzheimer's
longVida
dementia
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
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