NCT00110552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P75+ for phase_1 alzheimer-disease

Timeline
Completed

Started Jul 2005

Longer than P75 for phase_1 alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2005

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 29, 2014

Status Verified

October 1, 2014

Enrollment Period

7.4 years

First QC Date

May 10, 2005

Last Update Submit

October 27, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cognitive function

    8 weeks

Secondary Outcomes (2)

  • Stress

    8 weeks

  • cognitive electrophysiology

    8 weeks

Study Arms (2)

1

EXPERIMENTAL

Sage capsules taken by mouth

Drug: Salvia officinalis (sage)

2

NO INTERVENTION

No intervention, no-pill as control

Interventions

oral dosage

Also known as: sage
1

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Significant medical illness other than Alzheimer's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (2)

  • 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.

    PMID: 12605619BACKGROUND
  • 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.

    PMID: 12895683BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Barry Oken, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 10, 2005

First Posted

May 11, 2005

Study Start

July 1, 2005

Primary Completion

December 1, 2012

Study Completion

October 1, 2014

Last Updated

October 29, 2014

Record last verified: 2014-10

Locations