Targeting Default Mode Network Dysfunction in Persons At Risk of Alzheimer's Disease with Non-invasive Techniques

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-05

Study Completion Date

2024-12-04

Brief Summary

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Default mode network (DMN) dysfunction is a well-established feature of Alzheimer's Disease (AD) and is already present in preclinical stages and in subjects at risk for AD, thus offering a potential target for early intervention. Non-invasive stimulation techniques are candidate approaches to modulate network dysfunction, however interventions specifically targeting subjects at risk for AD are lacking. This project will test a non-invasive intervention to modulate the DMN in cognitively healthy older adults carrying the main genetic risk factor for AD, the APOE e4 allele. The proposal will non-invasively stimulate the DMN in at risk subjects and will assess the neuronal-cognitive effect of this approach with multimodal neuroimaging and neurophysiological techniques.

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Detailed Description

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Sixty-four participants will be enrolled (n=32 APOE e4 carriers, 32 non-carriers as reference group) and will undergo rTMS stimulation, TMS with concurrent electroencephalography (TMS-EEG), multimodal imaging (resting-state and task functional MRI, and diffusion tensor imaging) and cognitive assessment at baseline, after the intervention (week 1) and after 2 months. Participants will be randomized to 2 groups: active DMN stimulation (real-rTMS) or placebo (sham-rTMS). Each subject will undergo a rs-fMRI scan before the intervention to derive individualized DMN stimulation targets. rTMS will be applied over the left inferior parietal lobule node of the DMN.

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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real-rTMS

4 daily 25-minutes high-frequency rTMS sessions over one week

Group Type EXPERIMENTAL

real-rTMS

Intervention Type DEVICE

Each subject will undergo 4 rTMS sessions using a 70-mm figure-eight coil (20Hz for 25 minutes). Target localization will be performed with a stereotaxic neuronavigation system.

sham-rTMS

4 daily 25-minutes sham-rTMS sessions over one week

Group Type SHAM_COMPARATOR

sham-rTMS

Intervention Type DEVICE

The sham condition will match the real-rTMS protocol, but a sham coil will be used.

Interventions

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real-rTMS

Each subject will undergo 4 rTMS sessions using a 70-mm figure-eight coil (20Hz for 25 minutes). Target localization will be performed with a stereotaxic neuronavigation system.

Intervention Type DEVICE

sham-rTMS

The sham condition will match the real-rTMS protocol, but a sham coil will be used.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age: 60 years and older
* MMSE score \> 24

Exclusion Criteria

* Pathological scores in at least two standardized cognitive tests
* Participation in other interventional studies
* Known carriers of an autosomal dominant genetic mutation associated to AD
* Neurological, psychiatric or medical conditions not compatible with the study

* metal implants, pace-makers, prosthetic heart valves
* claustrophobia
* history of epilepsy
* pregnancy

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes