Efficacy and Safety of Curcumin Formulation in Alzheimer's Disease

NCT ID: NCT01001637

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-11-30

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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

curcumin

Group Type: ACTIVE_COMPARATOR

Curcumin Formulation

Intervention Type: DIETARY_SUPPLEMENT

2000mg or 3000mg daily BID

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Interventions

Curcumin Formulation

2000mg or 3000mg daily BID

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Longvida

Eligibility 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).

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharmanza Herbal Pvt Ltd

UNKNOWN

Sponsor Role: collaborator

Verdure Sciences

INDUSTRY

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

Jaslok Hospital and Research Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr Paresh Doshi

administrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fali Poncha, DM neuro

Role: STUDY_DIRECTOR

Jaslok Hospital and Research Centre

Locations

Jaslok Hospital and research centre

Mumbai, Maharashtra, India

Countries

India

Other Identifiers

919820711140

Identifier Type: -

Identifier Source: secondary_id

Longvida

Identifier Type: -

Identifier Source: org_study_id