Effects of Sage on Memory and Mental Performance in Alzheimer's Disease Patients

NCT ID: NCT00110552

Last Updated: 2014-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Sage capsules taken by mouth

Group Type EXPERIMENTAL

Salvia officinalis (sage)

Intervention Type DRUG

oral dosage

2

No intervention, no-pill as control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Salvia officinalis (sage)

oral dosage

Intervention Type DRUG

Other Intervention Names

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sage

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Barry S. Oken

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barry Oken, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health and Science University

Portland, Oregon, United States

Site Status

Countries

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United States

References

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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. doi: 10.1046/j.1365-2710.2003.00463.x.

Reference Type BACKGROUND
PMID: 12605619 (View on PubMed)

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. doi: 10.1016/s0091-3057(03)00108-4.

Reference Type BACKGROUND
PMID: 12895683 (View on PubMed)

Other Identifiers

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U19AT002656-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U19AT002656-03

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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