Clinical trial NCT00164749: A Pilot Study of Curcumin and Ginkgo for Treating Alzheimer's Disease
Official title: A Pilot Study of Curcumin and Ginkgo for Treating Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Alzheimer's Disease
Keywords: dementia
cognition
memory
neurodegenerative disease
brain
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: BUPA Foundation
name: Kwong Wah Hospital
First posted: 2005-09-14
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to develop procedures for testing the effectiveness of curcumin on slowing Alzheimer's disease (AD) progression.

Detailed description: A double-blind, randomized, clinical trial of 30 subjects will be carried out to develop procedures for testing the effectiveness of curcumin on slowing Alzheimer's disease (AD) progression. Curcumin is a polyphenolic molecule extracted from turmeric and is widely and safely used as a yellow food coloring. Because of its strong anti-inflammatory activity, curcumin was tested in animal models of AD, where it significantly reduced levels of brain amyloid, oxidized proteins, and isoprostanes, and prevented cognitive deficits. AD patients will receive placebo, 1 g, or 4 g of curcumin daily for six months. All patients will also receive 120 mg ginkgo leaf extract daily. At 0, 1, 3, and 6 months of the study, a cognitive test will be performed, and blood samples will be analyzed for levels of isoprostane, amyloid beta protein, metals, and cholesterol. Curcumin and its metabolites will be measured in blood at 1 month. The primary objective for this first human study of curcumin in AD is to examine safety and procedures for a possible larger trial testing curcumin against AD. The secondary objective is to determine whether curcumin affects biochemical measures, and, if so, which dose is most effective. The tertiary objective is to determine whether curcumin slows cognitive decline in AD. This study may lead to inexpensive treatment that delays progression of AD.

Eligibility criteria: Inclusion Criteria:

* Ethnic Chinese living in Hong Kong
* Progressive decline in memory and cognitive function for at least 6 months
* NINCDS-ADRDA diagnosis of possible or probable AD
* Mild to severe dementia with Cantonese version of MMSE scores between 0 and 28
* Informed consent from patient and/or caregiver
* Both elderly home residents and outpatients are eligible
* Patients may take any medication

Exclusion Criteria:

* Anticoagulant or antiplatelet treatment or bleeding risk factors
* Currently smoking
* Other severe, end-stage illness

Primary outcomes:
measure: Change in isoprostane level in plasma
timeFrame: 1 and 6 months
measure: Change in A-beta level in serum
timeFrame: 1 and 6 months
Secondary outcomes:
measure: Change in cognitive function (MMSE score)
timeFrame: 6 months
measure: Change in cholesterol and triglycerides in serum
timeFrame: 1 and 6 months
measure: Change in metals in serum
timeFrame: 1 month
measure: Level of curcumin in plasma vs. dose
timeFrame: 1 month
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Larry Baum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baum L, Lam CW, Cheung SK, Kwok T, Lui V, Tsoh J, Lam L, Leung V, Hui E, Ng C, Woo J, Chiu HF, Goggins WB, Zee BC, Cheng KF, Fong CY, Wong A, Mok H, Chow MS, Ho PC, Ip SP, Ho CS, Yu XW, Lai CY, Chan MH, Szeto S, Chan IH, Mok V. Six-month randomized, placebo-controlled, double-blind, pilot clinical trial of curcumin in patients with Alzheimer disease. J Clin Psychopharmacol. 2008 Feb;28(1):110-3. doi: 10.1097/jcp.0b013e318160862c. No abstract available.
citation: Baum L, Cheung SK, Mok VC, Lam LC, Leung VP, Hui E, Ng CC, Chow M, Ho PC, Lam S, Woo J, Chiu HF, Goggins W, Zee B, Wong A, Mok H, Cheng WK, Fong C, Lee JS, Chan MH, Szeto SS, Lui VW, Tsoh J, Kwok TC, Chan IH, Lam CW. Curcumin effects on blood lipid profile in a 6-month human study. Pharmacol Res. 2007 Dec;56(6):509-14. doi: 10.1016/j.phrs.2007.09.013. Epub 2007 Sep 18.