Trial | NCT00164749  Report issue

Official Title

A Pilot Study of Curcumin and Ginkgo for Treating Alzheimer's Disease

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    curcumin ginkgo biloba ...

  • Study Participants

    36
The purpose of this study is to develop procedures for testing the effectiveness of curcumin on slowing Alzheimer's disease (AD) progression.
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.
Study Started
Oct 31
2004
Primary Completion
Jul 31
2006
Study Completion
Jul 31
2006
Last Update
Apr 30
2008
Estimate

Drug Placebo and ginkgo extract

Placebo once daily, either as capsules or as powder to be mixed with food. All patients also received 120 mg/day standardized ginkgo leaf extract.

Drug Curcumin and ginkgo extract

1 g curcumin once daily, either as capsules or as powder to be mixed with food. All patients also received 120 mg/day standardized ginkgo leaf extract.

Drug Curcumin and ginkgo extract

4 g curcumin once daily, either as capsules or as powder to be mixed with food. All patients also received 120 mg/day standardized ginkgo leaf extract.

Placebo Placebo Comparator

Color-matched placebo

1 gram Experimental

1 g/day curcumin

4 gram Experimental

4 g/day curcumin

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
No Results Posted