Curcumin in Patients With Mild to Moderate Alzheimer's Disease - Full Text View

Sponsors and Collaborators:	John Douglas French Foundation Institute for the Study of Aging (ISOA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00099710

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	Drug: Curcumin C3 Complex	Phase II

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Cholesterol

Drug Information available for: Curcumin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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

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:

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.

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.

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 Abeta oligomers and fibrils and binds plaques and reduces amyloid in vivo. J Biol Chem. 2004 Dec 7; [Epub ahead of print]

Study ID Numbers:	IA0065
Study First Received:	December 17, 2004
Last Updated:	February 28, 2008
ClinicalTrials.gov Identifier:	NCT00099710
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

Curcumin
Turmeric
Curry
NSAID

anti-inflammatory
Cholesterol
anti-oxidant

Study placed in the following topic categories:

Turmeric extract
Curcumin
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Alzheimer disease

Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nervous System Diseases
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Tauopathies
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2009