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

Sponsor
Oregon Health and Science University (Other)
Overall Status
Completed
CT.gov ID
NCT00110552
Collaborator
National Center for Complementary and Integrative Health (NCCIH) (NIH)
111
Enrollment
1
Location
2
Arms
111
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: Salvia officinalis (sage)
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
111 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of a Cognitive Enhancer on Memory and Cognitive Performance
Study Start Date :
Jul 1, 2005
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Oct 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Sage capsules taken by mouth

Drug: Salvia officinalis (sage)
oral dosage
Other Names:
  • sage

    		•
    No Intervention: 2

    No intervention, no-pill as control

    Outcome Measures

    Primary Outcome Measures

    1. Cognitive function [8 weeks]

    Secondary Outcome Measures

    1. Stress [8 weeks]

    2. cognitive electrophysiology [8 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Oregon Health and Science University Portland Oregon United States 97239

    Sponsors and Collaborators

    • Oregon Health and Science University
    • National Center for Complementary and Integrative Health (NCCIH)

    Investigators

    • Principal Investigator: Barry Oken, MD, Oregon Health and Science University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Barry S. Oken, MD, Oregon Health and Science University
    ClinicalTrials.gov Identifier:
    NCT00110552
    Other Study ID Numbers:
    • U19AT002656-03
    • U19AT002656-03
    First Posted:
    May 11, 2005
    Last Update Posted:
    Oct 29, 2014
    Last Verified:
    Oct 1, 2014
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Oct 29, 2014