Trial record 1 of 1 for:    NCT00099710
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Curcumin in Patients With Mild to Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
Institute for the Study of Aging (ISOA)
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00099710
First received: December 17, 2004
Last updated: December 2, 2009
Last verified: December 2009
  Purpose

The purpose of this study is to examine the safety and tolerability of curcumin, and to determine its effect on patients with mild to moderate Alzheimer's Disease (AD).


Condition Intervention Phase
Alzheimer's Disease
Dietary Supplement: Curcumin C3 Complex
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase II, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of Two Doses of Curcumin C3 Complex Versus Placebo in Patients With Mild to Moderate Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Side effect checklist

Secondary Outcome Measures:
  • Oxidative damage
  • Inflammation/gliosis
  • A-beta levels
  • Tau levels
  • Total plasma cholesterol, LDL and HDL; ApoE
  • Plasma curcumin and metabolites
  • Cognitive and behavioral measures

Estimated Enrollment: 33
Study Start Date: July 2003
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Curcumin, a yellow substance found in the spice Turmeric, has antioxidant, non-steroidal anti-inflammatory (NSAID), and cholesterol-lowering properties, all of which make it a good candidate in the prevention and treatment of AD. The study will examine the safety and tolerability of 2 different doses of curcumin C3 complex. Blood and cerebrospinal fluid (CSF) tests will be used to examine how the curcumin is absorbed in the body, and whether it has an effect on inflammation, oxidative damage, and cholesterol levels. Participants will also be tested to determine the potential effect of curcumin on cognition, behavior, and daily function in patients with mild to moderate AD.

Participants will be randomly assigned to receive one of two doses of curcumin, or a placebo, for the initial 6 months of the trial. For the final 6 months, those receiving a placebo will be switched to one of the two doses of the drug. The 33 participants will make 7 visits to the study site over a 12-month period. These visits may include a physical and neurological examination, routine laboratory tests, lumbar puncture, and neuropsychological (mood and memory) evaluations.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female at least 50 years old
  • Diagnosis of probable AD
  • No history of significant psychiatric or non-AD neurological disease
  • Proficient in English to be able to perform cognitive testing
  • Caregiver available to monitor and administer medication and to accompany patient to every clinical visit
  • On stable doses of cholinesterase inhibitors and memantine (Alzheimer's medications) for 3 months prior to enrollment
  • On stable doses of all other allowed medications for at least one month prior to starting the study medication

Exclusion Criteria:

  • Current or recent major psychiatric illness (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
  • Familial, autosomal dominant Alzheimer's disease due to a mutation in a known gene (Presenilin-1, Presenilin-2, or Amyloid Precursor Protein)
  • NSAIDs (e.g. ibuprofen, naproxen, etc.) taken on a regular basis (more than 3 times per week)
  • Aspirin at doses more than 325 mg per day
  • Coumadin, heparin, other anticoagulants
  • Antioxidants or other supplements including gingko biloba, coenzyme Q10, alpha-lipoic acid
  • Vitamin E at doses more than 2,000 IU per day
  • Vitamin C at doses more than 500 mg per day
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099710

Locations
United States, California
UCLA Medical Center
Westwood, California, United States
Sponsors and Collaborators
John Douglas French Foundation
Institute for the Study of Aging (ISOA)
Investigators
Study Director: John Ringman, MD University of California, Los Angeles
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00099710     History of Changes
Other Study ID Numbers: IA0065
Study First Received: December 17, 2004
Last Updated: December 2, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Curcumin
Turmeric
Curry
NSAID
anti-inflammatory
Cholesterol
anti-oxidant

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014