Efficacy and Safety of Curcumin Formulation in Alzheimer's Disease

Not Applicable

Terminated

• Conditions: Alzheimer Disease
• Interventions: Dietary Supplement: Curcumin Formulation; Dietary Supplement: Placebo

• Registration Number: NCT01001637
• Lead Sponsor: Jaslok Hospital and Research Centre

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.

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 Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2009-10-23
• Study First Posted: 2009-10-26
• Primary Completion: 2010-06
• Study Completion: 2010-11
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
curcumin	Curcumin Formulation	-
placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
To determine if curcumin formulation affects mental capacity in Alzheimer's patients based on mental exams	60 days

Secondary Outcome Measures

Name	Time	Method
To determine if curcumin formulation changes blood concentrations of amyloid-beta	60 days

Trial Locations

Locations (1)

Jaslok Hospital and research centre; 🇮🇳 Mumbai, Maharashtra, India