search
Back to results

Curcumin in Patients With Mild to Moderate Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Curcumin C3 Complex
Sponsored by
John Douglas French Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Curcumin, Turmeric, Curry, NSAID, anti-inflammatory, Cholesterol, anti-oxidant

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA Medical Center

Outcomes

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

Full Information

First Posted
December 17, 2004
Last Updated
December 2, 2009
Sponsor
John Douglas French Foundation
Collaborators
Institute for the Study of Aging (ISOA)
search

1. Study Identification

Unique Protocol Identification Number
NCT00099710
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
John Douglas French Foundation
Collaborators
Institute for the Study of Aging (ISOA)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Curcumin, Turmeric, Curry, NSAID, anti-inflammatory, Cholesterol, anti-oxidant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
Curcumin C3 Complex
Primary Outcome Measure Information:
Title
Side effect checklist
Secondary Outcome Measure Information:
Title
Oxidative damage
Title
Inflammation/gliosis
Title
A-beta levels
Title
Tau levels
Title
Total plasma cholesterol, LDL and HDL; ApoE
Title
Plasma curcumin and metabolites
Title
Cognitive and behavioral measures

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Ringman, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Study Director
Facility Information:
Facility Name
UCLA Medical Center
City
Westwood
State/Province
California
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11571321
Citation
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.
Results Reference
background
PubMed Identifier
11606625
Citation
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.
Results Reference
background
PubMed Identifier
15590663
Citation
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.
Results Reference
background
PubMed Identifier
23107780
Citation
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.
Results Reference
derived

Learn more about this trial

Curcumin in Patients With Mild to Moderate Alzheimer's Disease

We'll reach out to this number within 24 hrs