Effects of a Cognitive Enhancer on Memory and Cognitive Performance
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 111
- Locations
- 1
- Primary Endpoint
- Cognitive function
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 90 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
1
Sage capsules taken by mouth
Intervention: Salvia officinalis (sage) (Drug)
Outcomes
Primary Outcomes
Cognitive function
Time Frame: 8 weeks
Secondary Outcomes
- cognitive electrophysiology(8 weeks)
- Stress(8 weeks)
Investigators
Barry S. Oken
MD
Oregon Health and Science University