Efficacy and Safety of Curcumin Formulation in Alzheimer's Disease

NCT01001637 | Terminated

• 2 other identifiers: Longvida919820711140
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

curcumin; alzheimer's; longVida; dementia

Outcome Measures

Primary Outcomes (1)

• To determine if curcumin formulation affects mental capacity in Alzheimer's patients based on mental exams

  60 days

Secondary Outcomes (1)

• To determine if curcumin formulation changes blood concentrations of amyloid-beta

  60 days

Study Arms (2)

curcumin

ACTIVE COMPARATOR

Dietary Supplement: Curcumin Formulation

placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Curcumin Formulation DIETARY_SUPPLEMENT

2000mg or 3000mg daily BID

Also known as: Longvida

curcumin

Placebo DIETARY_SUPPLEMENT

Placebo

placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jaslok Hospital and Research Centre: lead
• Pharmanza Herbal Pvt Ltd: collaborator
• Verdure Sciences: collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

Jaslok Hospital and research centre

Mumbai, Maharashtra, 400026, India

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Fali Poncha, DM neuro

  Jaslok Hospital and Research Centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: administrator

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: October 26, 2009
• Study Start: October 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: November 1, 2010
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

IN (1)