Effects of Sage on Memory and Mental Performance in Alzheimer's Disease Patients
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Salvia officinalis (sage)
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility 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
Sites / Locations
- Oregon Health and Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Sage capsules taken by mouth
No intervention, no-pill as control
Outcomes
Primary Outcome Measures
Cognitive function
Secondary Outcome Measures
Stress
cognitive electrophysiology
Full Information
NCT ID
NCT00110552
First Posted
May 10, 2005
Last Updated
October 27, 2014
Sponsor
Oregon Health and Science University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00110552
Brief Title
Effects of Sage on Memory and Mental Performance in Alzheimer's Disease Patients
Official Title
Effects of a Cognitive Enhancer on Memory and Cognitive Performance
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Sage capsules taken by mouth
Arm Title
2
Arm Type
No Intervention
Arm Description
No intervention, no-pill as control
Intervention Type
Drug
Intervention Name(s)
Salvia officinalis (sage)
Other Intervention Name(s)
sage
Intervention Description
oral dosage
Primary Outcome Measure Information:
Title
Cognitive function
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Stress
Time Frame
8 weeks
Title
cognitive electrophysiology
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry Oken, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12605619
Citation
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.
Results Reference
background
PubMed Identifier
12895683
Citation
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.
Results Reference
background
Learn more about this trial
Effects of Sage on Memory and Mental Performance in Alzheimer's Disease Patients
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