Curcumin in Patients With Mild to Moderate Alzheimer's Disease

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099710
• Other study ID #: IA0065
• Status: Completed
• Phase: Phase 2
• First received: December 17, 2004
• Last updated: December 2, 2009
• Start date: July 2003
• Est. completion date: December 2007

Study information

• Verified date: December 2009
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Dietary Supplement:
• Curcumin C3 Complex

Locations

Country	Name	City	State
United States	UCLA Medical Center	Westwood	California

Sponsors (2)

Lead Sponsor	Collaborator
John Douglas French Foundation	Institute for the Study of Aging (ISOA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. Epub 2004 Dec 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Side effect checklist
Secondary	Oxidative damage
Secondary	Inflammation/gliosis
Secondary	A-beta levels
Secondary	Tau levels
Secondary	Total plasma cholesterol, LDL and HDL; ApoE
Secondary	Plasma curcumin and metabolites
Secondary	Cognitive and behavioral measures