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| Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
|---|---|
| Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
| ClinicalTrials.gov Identifier: | NCT00110552 |
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 I |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Effects of a Cognitive Enhancer on Memory and Cognitive Performance |
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Sage capsules taken by mouth
|
Drug: Salvia officinalis (sage)
oral dosage
|
|
2: No Intervention
No intervention, no-pill as control
|
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:
Exclusion Criteria:
Contacts and Locations| Contact: Aisha Kudura, BA | 503-494-5650 | kuduraa@ohsu.edu |
| United States, Oregon | |
| Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Aisha Kudura, BA 503-494-5650 kuduraa@ohsu.edu | |
| Contact: Daniel Zajdel, BA 503-494-5650 zajdeld@ohsu.edu | |
| Principal Investigator: Barry Oken, MD | |
| Principal Investigator: | Barry Oken, MD | Oregon Health and Science University |
More Information
| Responsible Party: | Oregon Health & Science University ( Barry Oken, M.D. ) |
| Study ID Numbers: | U19 AT002656-03 |
| Study First Received: | May 10, 2005 |
| Last Updated: | September 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00110552 History of Changes |
| Health Authority: | United States: Federal Government |
|
Nootropic Agents Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
|
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nervous System Diseases Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Tauopathies Brain Diseases Dementia |
