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Curcumin in Patients With Mild to Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00099710
First Posted: December 20, 2004
Last Update Posted: December 3, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Institute for the Study of Aging (ISOA)
Information provided by:
National Institute on Aging (NIA)
December 17, 2004
December 20, 2004
December 3, 2009
July 2003
December 2007   (Final data collection date for primary outcome measure)
Side effect checklist
Same as current
Complete list of historical versions of study NCT00099710 on ClinicalTrials.gov Archive Site
  • Oxidative damage
  • Inflammation/gliosis
  • A-beta levels
  • Tau levels
  • Total plasma cholesterol, LDL and HDL; ApoE
  • Plasma curcumin and metabolites
  • Cognitive and behavioral measures
Same as current
Not Provided
Not Provided
 
Curcumin in Patients With Mild to Moderate Alzheimer's Disease
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
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).

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Alzheimer's Disease
Dietary Supplement: Curcumin C3 Complex
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
December 2007
December 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00099710
IA0065
Not Provided
Not Provided
Not Provided
Not Provided
John Douglas French Foundation
Institute for the Study of Aging (ISOA)
Study Director: John Ringman, MD University of California, Los Angeles
National Institute on Aging (NIA)
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP