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Curcumin in Patients With Mild to Moderate Alzheimer's Disease

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.
 
ClinicalTrials.gov Identifier: NCT00099710
Recruitment Status : Completed
First Posted : December 20, 2004
Last Update Posted : December 3, 2009
Sponsor:
Collaborator:
Institute for the Study of Aging (ISOA)
Information provided by:
National Institute on Aging (NIA)

Tracking Information
First Submitted Date  ICMJE December 17, 2004
First Posted Date  ICMJE December 20, 2004
Last Update Posted Date December 3, 2009
Study Start Date  ICMJE July 2003
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Side effect checklist
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Oxidative damage
  • Inflammation/gliosis
  • A-beta levels
  • Tau levels
  • Total plasma cholesterol, LDL and HDL; ApoE
  • Plasma curcumin and metabolites
  • Cognitive and behavioral measures
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Curcumin in Patients With Mild to Moderate Alzheimer's Disease
Official Title  ICMJE 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
Brief Summary 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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE Dietary Supplement: Curcumin C3 Complex
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 23, 2005)
33
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00099710
Other Study ID Numbers  ICMJE IA0065
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE John Douglas French Foundation
Collaborators  ICMJE Institute for the Study of Aging (ISOA)
Investigators  ICMJE
Study Director: John Ringman, MD University of California, Los Angeles
PRS Account National Institute on Aging (NIA)
Verification Date December 2009

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