Effects of Sage on Memory and Mental Performance in Alzheimer's Disease Patients
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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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Effects of a Cognitive Enhancer on Memory and Cognitive Performance |
- Cognitive function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- 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: | January 2013 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Sage capsules taken by mouth
|
Drug: Salvia officinalis (sage)
oral dosage
Other Name: sage
|
|
No Intervention: 2
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 |
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| United States, Oregon | |
| Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| Principal Investigator: | Barry Oken, MD | Oregon Health and Science University |
More Information
Publications:
| Responsible Party: | Barry S. Oken, MD, Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT00110552 History of Changes |
| Other Study ID Numbers: | U19 AT002656-03, U19AT002656-03 |
| Study First Received: | May 10, 2005 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nootropic Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013