Efficacy and Safety of Curcumin Formulation in Alzheimer's Disease

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

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.

Study Overview

• Status: Terminated
• Conditions: Alzheimer Disease
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Curcumin Formulation

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fali Poncha, MD; Phone Number: 9820711140; Email: fali@rediffmail.com
• Study Contact Backup: Name: Nitin Kochar, MD; Phone Number: 9819702151; Email: nitinkochar@gmail.com

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400026
      • Jaslok Hospital and Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Dietary supplement: Placebo; Placebo
Active Comparator: curcumin	Dietary supplement: Curcumin Formulation; 2000mg or 3000mg daily BID; Other Names: Longvida

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine if curcumin formulation affects mental capacity in Alzheimer's patients based on mental exams	60 days

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine if curcumin formulation changes blood concentrations of amyloid-beta	60 days

Collaborators and Investigators

• Sponsor: Jaslok Hospital and Research Centre
• Collaborators: University of California, Los Angeles; Verdure Sciences; Pharmanza Herbal Pvt Ltd
• Investigators: Study Director: Fali Poncha, DM neuro, Jaslok Hospital and Research Centre

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: October 15, 2009
• First Submitted That Met QC Criteria: October 23, 2009
• First Posted (Estimated): October 26, 2009

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: dementia; curcumin; alzheimer's; longVida
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: Longvida; 919820711140