Effects of Sage on Memory and Mental Performance in Alzheimer's Disease Patients - Full Text View

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00110552

Purpose

The purpose of this study is to determine the effectiveness of the herb sage in improving the mental function of individuals with Alzheimer's disease.

Study hypothesis: The administration of sage will improve cognitive function in patients with mild Alzheimer's disease.

Condition	Intervention	Phase
Alzheimer Disease	Drug: Salvia officinalis (sage)	Phase I

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effects of a Cognitive Enhancer on Memory and Cognitive Performance

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Memory

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

Cognitive function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Stress [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
cognitive electrophysiology [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	July 2005
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Sage capsules taken by mouth	Drug: Salvia officinalis (sage) oral dosage
2: No Intervention No intervention, no-pill as control

Detailed Description:

The herb sage has been shown to enhance memory and mental function in healthy, young adults. However, studies assessing the herb's effectiveness in older adults with symptoms of Alzheimer's disease are limited. This study will determine the effect of sage extract on the cognitive function of patients with mild Alzheimer's disease.

This study will last 6 weeks and will comprise 4 study visits, approximately 10 days apart. Participants will be randomly assigned to receive either sage pills or no treatment during each 10-day period. The treatment assignments will be switched in 10-day intervals, so that during the course of the study, each participant will undergo two periods of sage treatment and two periods without treatment. At each study visit, participants will undergo cognitive testing, including tests to determine attention, memory, and visual cognition. Participants will also undergo an electroencephalogram (EEG) and an electrocardiogram (ECG) at each visit.

Eligibility

Ages Eligible for Study:	50 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of mild Alzheimer's disease
Partner, friend, child, spouse, or relative willing to accompany participants to all study visits, provide informed consent, monitor participants' pill-taking, and communicate changes in participants' health during the study

Exclusion Criteria:

Significant medical illness other than Alzheimer's disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110552

Contacts

Contact: Aisha Kudura, BA

503-494-5650

kuduraa@ohsu.edu

Locations

United States, Oregon
Oregon Health and Science University	Recruiting
Portland, Oregon, United States, 97239
Contact: Aisha Kudura, BA 503-494-5650 kuduraa@ohsu.edu
Contact: Daniel Zajdel, BA 503-494-5650 zajdeld@ohsu.edu
Principal Investigator: Barry Oken, MD

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Barry Oken, MD

Oregon Health and Science University

More Information

Publications:

Akhondzadeh S, Noroozian M, Mohammadi M, Ohadinia S, Jamshidi AH, Khani M. Salvia officinalis extract in the treatment of patients with mild to moderate Alzheimer's disease: a double blind, randomized and placebo-controlled trial. J Clin Pharm Ther. 2003 Feb;28(1):53-9.

Perry NS, Bollen C, Perry EK, Ballard C. Salvia for dementia therapy: review of pharmacological activity and pilot tolerability clinical trial. Pharmacol Biochem Behav. 2003 Jun;75(3):651-9. Review.

Responsible Party:	Oregon Health & Science University ( Barry Oken, M.D. )
Study ID Numbers:	U19 AT002656-03
Study First Received:	May 10, 2005
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00110552 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurodegenerative Diseases
Central Nervous System Diseases
Brain Diseases
Alzheimer Disease

Nootropic Agents
Pharmacologic Actions
Therapeutic Uses
Dementia
Tauopathies
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2009