Theta Burst Stimulation for Mild to Moderate Alzheimer's disease.

Not Applicable

Recruiting

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

• Registration Number: ACTRN12623000668606
• Lead Sponsor: Bionics Institute of Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-21
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

Participants will be included if they:
(1) are between 50 and 85 years of age;
(2) have a diagnosis of 'probable Alzheimer's disease (AD) dementia' according to the National Institute on Aging/Alzheimer's Association diagnostic guidelines of AD (NIA-AA)
(3) meet criteria for mild or moderate AD as indicated by a score >12 on the Mini-Mental State Evaluation;
(4) are competent to consent based on their ability to provide a spontaneous narrative description of the key elements of the study, or, if they are unable to consent, consent may be provided on their behalf by a legally authorized representative, who may be a family member, legal guardian, or other designated representative as consistent with the relevant state and federal legislation applicable for each study site. Where participants can consent an advance care directive will be taken, whereby if they lose capacity to consent during the trial they can choose to either withdraw or for consent to be sought from their legally authorized representative. In all instances where consent is provided by the participant's legally authorized representative, the participant's willingness to participate (i.e., assent) will be required and documented.
(5) are either not on a cholinesterase inhibitor and/or memantine or have been on a stable dose for at least 3 months prior to screening;
(6) are either not on a psychotropic medication or their dose of psychotropic medication has been unchanged for at least 4 weeks prior to study entry. Psychotropic dose will not be able to be altered during the trial: if this is clinically required the participant will be withdrawn;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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional Connectivity as measured using resting state functional Magnetic Resonance Imaging (rs-fMRI). [ This outcome will be measured at baseline and at the end of treatment (i.e. week 12 post baseline, primary timepoint)<br>];The Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog).<br><br>[ This outcome will be measured at baseline, end of treatment (Week 12 post-baseline, primary timepoint), 3, 6 and 12 month follow-ups post-completion of treatment.];Clinical Dementia Rating Sum of Boxes (CDR-SB, composite scale for cognition and function) [ This outcome will be measured at baseline, end of treatment (Week 12 post-baseline, primary timepoint), 3, 6 and 12 month follow-ups post-completion of treatment.]