Clinical trial NCT00110552: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2005-05-11
Enrollment: 111
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cognitive function
timeFrame: 8 weeks
Secondary outcomes:
measure: Stress
timeFrame: 8 weeks
measure: cognitive electrophysiology
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Barry Oken, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.