Investigating a Novel Brain Stimulation Treatment for Mild Alzheimer's Disease

Not Applicable

Completed

• Conditions: Mild Alzheimer's Disease; Neurological - Alzheimer's disease

• Registration Number: ACTRN12619000010190
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-08
• Study Completion: 2022-05-24
• Last Update Posted: 13 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Aged between 50-85 years
-Demonstrated ability to give informed consent
-Diagnosis of probable AD according to the National Institute of Neurological and Communication Disorders–Alzheimer’s Disease and Related Disorders Association (NINCDS–ADRDA) criteria
-Meet criteria for mild AD as indicated by a score of greater than 19 on the Mini-Mental State Evaluation (MMSE)
-Not on a cholinesterase inhibitor or memantine or have been on a stable dose for at least two months prior to screening
-Not on psychotropic medication or their dose of psychotropic medication has been unchanged for a minimum of 4 weeks prior to entry into the study
-Frequent contact with a caregiver who can provide information on the participant’s cognitive and functional abilities at study visits and assist with at home stimulation procedures where required
-Able to participate in cognitive testing in English

Exclusion Criteria

-Concomitant major and unstable medical, psychiatric or neurological illness
-Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in verbal episodic memory, as measured by change in Rey Auditory Verbal Learning Test (RAVLT) total score.[Assessed at baseline, end of treatment (primary endpoint), and at the 6-week and 3-month follow-up appointments.];Gamma power, as measured using resting EEG.[Assessed at baseline and at the end of the treatment course.];Connectivity, as measured using resting EEG.[Assessed at baseline and at the end of the treatment course.]