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
Recruitment status was Recruiting
Sponsor:
Jaslok Hospital and Research Centre
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
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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:
Genetics Home Reference related topics:
Alzheimer disease
Drug Information available for:
Curcumin
U.S. FDA Resources
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 June 18, 2013