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Trial record 3 of 6 for:    curcumin | Alzheimer Disease

Curcumin in Patients With Mild to Moderate Alzheimer's Disease

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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)

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).

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Dietary Supplement: Curcumin C3 Complex Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : July 2003
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin




Primary Outcome Measures :
  1. Side effect checklist

Secondary Outcome Measures :
  1. Oxidative damage
  2. Inflammation/gliosis
  3. A-beta levels
  4. Tau levels
  5. Total plasma cholesterol, LDL and HDL; ApoE
  6. Plasma curcumin and metabolites
  7. Cognitive and behavioral measures


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00099710     History of Changes
Other Study ID Numbers: IA0065
First Posted: December 20, 2004    Key Record Dates
Last Update Posted: December 3, 2009
Last Verified: December 2009

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

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