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
  Purpose

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 Intervention Phase
Alzheimer Disease
Dietary Supplement: Curcumin Formulation
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Jaslok Hospital and Research Centre:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To determine if curcumin formulation changes blood concentrations of amyloid-beta [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: October 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: curcumin Dietary Supplement: Curcumin Formulation
2000mg or 3000mg daily BID
Other Name: Longvida
Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001637

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

Locations
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
Study Director: Fali Poncha, DM neuro Jaslok Hospital and Research Centre
  More Information

No publications provided

Responsible Party: Dr Fali Poncha, Jaslok Hospital and Research centre
ClinicalTrials.gov Identifier: NCT01001637     History of Changes
Other Study ID Numbers: Longvida, 919820711140
Study First Received: October 15, 2009
Last Updated: October 23, 2009
Health Authority: India: Drugs Controller General of India

Keywords provided by Jaslok Hospital and Research Centre:
curcumin
alzheimer's
longVida
dementia

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014