N/A N=45 Randomized Triple-blind Treatment

Non-invasive Stimulation of Brain Networks and Cognition in Alzheimer's Disease and Frontotemporal Dementia

Alzheimer's Disease · Frontotemporal Dementia, Behavioral Variant

Bottom Line

View on ClinicalTrials.gov: NCT03422250 ↗

Enrolled (actual)

Serious AEs

2.2%

Results posted

Apr 2021

Primary outcome: Primary: Change in Clinical Disease Severity (CDR) — -0.1; 0.0; 0.0; 0.0 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: transcranial direct current stimulation (tDCS) (Device)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
Primary completion: Nov 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Clinical Disease Severity (CDR)	-0.1; 0.0; 0.0; 0.0; 0.1; 0.0	—
PRIMARY Change in Behavioral Symptom Severity (NPI)	-1; -3; -1; -6	—
PRIMARY Change in Behavioral Symptom Severity (FBI)	-2; -4	—
PRIMARY Change in Functional Connectivity	0.08; -0.09; -0.02; -0.04; -0.06; 0.05	—
PRIMARY Change in Cerebral Blood Flow	4.87; -0.06; 0.56; 3.08; 4.37; -1.92	—
SECONDARY Change in Cognition: Memory	0.3; 0.3; 0.1; 0.2	—
SECONDARY Change in Cognition: Language	0.7; 0.4; 0.7; 0.4	—
SECONDARY Change in Cognition: Executive Function	0.3; -0.3; 0.7; -0.7	—
SECONDARY Change in Cognition: Visuospatial Function	1.2; 0.0; 0.1; 0.4	—
SECONDARY Change in Cognition: Emotion Recognition	0.1; 0.1; 0.3; 0.1	—
SECONDARY Change in Structural Connectivity: FA	0.000; -0.003; -0.002; 0.000; 0.003; -0.002	—
SECONDARY Change in Structural Connectivity: MD, AxD, RaD	-0.003; -0.001; 0.007; 0.007; -0.004; -0.002	—

Summary

This pilot study aims to test clinical and connectivity changes following non-invasive stimulation of disease-specific networks in Alzheimer's disease (AD) and behavioral variant frontotemporal dementia (bvFTD). Brain network stimulation will be carried out with transcranial direct current stimulation (tDCS). Target networks will be the default mode network (DMN) and salience network (SN). Twenty AD and 20 bvFTD patients will be recruited and assessed with a comprehensive clinical, behavioral and cognitive battery, and 3 Tesla MRI scan (including resting-state functional MRI, arterial spin labeling, diffusion tensor imaging, structural MRI) at three time-points: baseline, after tDCS, and after 6 months. Patients will be randomized to 2 arms: anodal stimulation of the disease-specific network (DMN in AD, SN in bvFTD) or cathodal stimulation of the anti-correlated network (SN in AD, DMN in bvFTD). The intervention will consist of 10 tDCS sessions over two weeks. Cerebrospinal fluid (CSF) samples will be collected at baseline for biomarker's assessment; blood samples will be collected at each time-point to assess changes in peripheral inflammatory markers. Blood and CSF collection will be optional. A sample of 20 elderly controls will be included for baseline comparisons.

Eligibility Criteria

Inclusion Criteria

Diagnosis of AD or bvFTD according to current clinical criteria (Albert et al., 2011; Rascovsky et al., 2011)
Ability to provide written informed consent
Availability of a collateral source

Exclusion Criteria

Moderate/severe dementia
Presence of any medical or psychiatric illness that could interfere in completing assessments

Exclusion Criteria for MRI and tDCS:

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

Exclusion Criteria for controls:

Current or past history of clinical, neurological, or psychiatric conditions that could interfere with the assessment (e.g., transient ischemic attack, ictus, head trauma, epilepsy, multiple sclerosis, neuropathy, mood disorders, substance abuse)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03422250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.