Efficacy and Safety of Curcumin Formulation in Alzheimer's Disease

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01001637
• Other study ID #: Longvida
• Secondary ID: 919820711140
• Status: Terminated
• Phase: N/A
• Start date: October 2009
• Est. completion date: November 2010

Study information

• Verified date: September 2023
• Source: Jaslok Hospital and Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: November 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Dietary Supplement:
• Curcumin Formulation
2000mg or 3000mg daily BID
• Placebo
Placebo

Locations

Country	Name	City	State
India	Jaslok Hospital and research centre	Mumbai	Maharashtra

Sponsors (4)

Lead Sponsor	Collaborator
Jaslok Hospital and Research Centre	Pharmanza Herbal Pvt Ltd, University of California, Los Angeles, Verdure Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if curcumin formulation affects mental capacity in Alzheimer's patients based on mental exams		60 days
Secondary	To determine if curcumin formulation changes blood concentrations of amyloid-beta		60 days