Curcumin in Patients With Mild to Moderate Alzheimer's Disease

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

Tracking Information

• First Submitted Date: December 17, 2004
• First Posted Date: December 20, 2004
• Last Update Posted Date: December 3, 2009
• Study Start Date: July 2003
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 23, 2005): Side effect checklist
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Curcumin in Patients With Mild to Moderate Alzheimer's Disease
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Alzheimer's Disease
• Intervention: Dietary Supplement: Curcumin C3 Complex
• Study Arms: Not Provided

Publications *

• Chandra V, Pandav R, Dodge HH, Johnston JM, Belle SH, DeKosky ST, Ganguli M. Incidence of Alzheimer's disease in a rural community in India: the Indo-US study. Neurology. 2001 Sep 25;57(6):985-9. doi: 10.1212/wnl.57.6.985.
• Lim GP, Chu T, Yang F, Beech W, Frautschy SA, Cole GM. The curry spice curcumin reduces oxidative damage and amyloid pathology in an Alzheimer transgenic mouse. J Neurosci. 2001 Nov 1;21(21):8370-7. doi: 10.1523/JNEUROSCI.21-21-08370.2001.
• Yang F, Lim GP, Begum AN, Ubeda OJ, Simmons MR, Ambegaokar SS, Chen PP, Kayed R, Glabe CG, Frautschy SA, Cole GM. Curcumin inhibits formation of amyloid beta oligomers and fibrils, binds plaques, and reduces amyloid in vivo. J Biol Chem. 2005 Feb 18;280(7):5892-901. doi: 10.1074/jbc.M404751200. Epub 2004 Dec 7.
• Ringman JM, Frautschy SA, Teng E, Begum AN, Bardens J, Beigi M, Gylys KH, Badmaev V, Heath DD, Apostolova LG, Porter V, Vanek Z, Marshall GA, Hellemann G, Sugar C, Masterman DL, Montine TJ, Cummings JL, Cole GM. Oral curcumin for Alzheimer's disease: tolerability and efficacy in a 24-week randomized, double blind, placebo-controlled study. Alzheimers Res Ther. 2012 Oct 29;4(5):43. doi: 10.1186/alzrt146. eCollection 2012.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: June 23, 2005): 33
• Original Enrollment: Same as current
• Actual Study Completion Date: December 2007
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00099710
• Other Study ID Numbers: IA0065
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: John Douglas French Foundation
• Original Study Sponsor: Same as current
• Collaborators: Institute for the Study of Aging (ISOA)

Investigators

• Study Director: John Ringman, MD; University of California, Los Angeles

• PRS Account: National Institute on Aging (NIA)
• Verification Date: December 2009