A randomised controlled trial of acute and maintenance Theta Burst Stimulation for mild to moderate Alzheimer's

Not Applicable

Withdrawn

• Conditions: Alzheimer’s disease; Neurological - Alzheimer's disease

• Registration Number: ACTRN12621000620820
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Participants will be included if they:
(1) are between 50 and 85 years;
(2) are competent to consent based on their ability to provide a spontaneous narrative description of the key elements of the study, as assessed by an independent clinical staff member. Participants will complete an advanced care directive to allow for the possibility they may lose capacity during the trial;
(3) have a diagnosis of probable Alz according to the National Institute on Aging /Alzheimer's Association diagnostic guidelines for Alzheimer's disease (NIA-AA)
(4) meet criteria for mild or moderate Alz as indicated by >12 on the Mini-Mental State Evaluation; (5) are either not on a cholinesterase inhibitor or memantine or have been on a stable dose for at least 2 months prior to screening;
(6) are either not on psychotropic medication or their dose of psychotropic medication has been unchanged for at least 4 weeks prior to study entry. Psychotropic medication dose will not be able to be altered during the trial: if this is clinically required the participant will be withdrawn;
(7) have frequent contact with a close other who can provide information on the participant’s cognitive and functional abilities;
(8) are able to participate in cognitive testing in English.

Exclusion Criteria

Participants will be excluded if they:
(1) have a concomitant major and unstable medical, psychiatric or neurological illness or seizure disorder history;
(2) are pregnant;
(3) have medically implanted material that could interact with the magnetic field.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Episodic verbal memory, using a word list learning task. <br><br>[- at the end of the acute treatment phase (i.e. week 6) (primary endpoint). <br><br>- at the end of the maintenance treatment phase (i.e. week 18). <br><br>- at 3 and 6-month post treatment follow up.]