Effects of Sage on Memory and Mental Performance in Alzheimer's Disease Patients

• ClinicalTrials.gov Identifier: NCT00110552
• Recruitment Status: Completed
• First Posted: May 11, 2005
• Last Update Posted: October 29, 2014
• Sponsor: Oregon Health and Science University
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): Barry S. Oken, Oregon Health and Science University

Tracking Information

• First Submitted Date: May 10, 2005
• First Posted Date: May 11, 2005
• Last Update Posted Date: October 29, 2014
• Study Start Date: July 2005
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 24, 2008): Cognitive function [ Time Frame: 8 weeks ]
• Original Primary Outcome Measures (submitted: June 23, 2005): Cognitive function

Current Secondary Outcome Measures (submitted: September 24, 2008)

• Stress [ Time Frame: 8 weeks ]
• cognitive electrophysiology [ Time Frame: 8 weeks ]

Original Secondary Outcome Measures (submitted: June 23, 2005)

• Stress
• cognitive electrophysiology

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Alzheimer Disease

Intervention

Drug: Salvia officinalis (sage)

oral dosage

Other Name: sage

Study Arms

• Experimental: 1
  Sage capsules taken by mouth
  Intervention: Drug: Salvia officinalis (sage)
• No Intervention: 2
  No intervention, no-pill as control

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 27, 2014): 111
• Original Enrollment (submitted: June 23, 2005): 40
• Actual Study Completion Date: October 2014
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00110552
• Other Study ID Numbers: U19AT002656-03( U.S. NIH Grant/Contract ); U19AT002656-03 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Barry S. Oken, Oregon Health and Science University
• Original Responsible Party: Not Provided
• Current Study Sponsor: Oregon Health and Science University
• Original Study Sponsor: National Center for Complementary and Integrative Health (NCCIH)
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Barry Oken, MD; Oregon Health and Science University

• PRS Account: Oregon Health and Science University
• Verification Date: October 2014