Status:
TERMINATED
Efficacy and Safety of Curcumin Formulation in Alzheimer's Disease
Lead Sponsor:
Jaslok Hospital and Research Centre
Collaborating Sponsors:
Pharmanza Herbal Pvt Ltd
Verdure Sciences
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50-80 years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01001637
Start Date
October 1 2009
End Date
November 1 2010
Last Update
September 28 2023
Active Locations (1)
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1
Jaslok Hospital and research centre
Mumbai, Maharashtra, India, 400026