Alzheimer's DiseaseNetCogBsNCT03422250
Non-invasive Stimulation of Brain Networks and Cognition in Alzheimer's Disease and Frontotemporal Dementia
A study testing transcranial direct current stimulation (tDCS) in people with Alzheimer's Disease and Frontotemporal Dementia, Behavioral Variant, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Frontotemporal Dementia, Behavioral Variant
- What is being tested?
- transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jun 2015to 3 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Moderate/severe dementia
- Presence of any medical or psychiatric illness that could interfere in completing assessments
- metal implants, pace-makers, prosthetic heart valves
- claustrophobia
- history of epilepsy
- pregnancy
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-invasive, Multimodal Approach to Restore Functional Networks and Cognition in Alzheimer's Disease and Frontotemporal Dementia
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.
- Being tested
- transcranial direct current stimulation (tDCS)
- Medical subject headings
- Alzheimer Disease, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation (tDCS)Device
10 daily 25-minutes tDCS sessions over two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Alzheimer's disease (AD): anodal tDCS of the default mode network (DMN) Receives: Device: transcranial direct current stimulation (tDCS) |
| Arm 2 | Experimental | Alzheimer's disease (AD): cathodal tDCS of the salience network (SN) Receives: Device: transcranial direct current stimulation (tDCS) |
| Arm 3 | Experimental | Behavioral-variant frontotemporal dementia (bvFTD): anodal tDCS of the salience network (SN) Receives: Device: transcranial direct current stimulation (tDCS) |
| Arm 4 | Experimental | Behavioral-variant frontotemporal dementia (bvFTD): cathodal tDCS of the default mode network (DMN) Receives: Device: transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Disease Severity (CDR)
CDR - Clinical Dementia Rating score
The clinical dementia rating (CDR) is a clinical global rating scale administered to both the participant and the caregiver, assessing 6 domains of participant function: memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care. Each domain is based on a 5-point scale ranging from no impairment=0, questionable impairment=0.5, mild impairment=1, moderate impairment=2 to severe impairment=3. The global CDR score is computed via a memory-weighted averaging algorithm of the six domain scores and ranges from 0 to 5. The CDR-sum of boxes (CDR-SB) is the sum of the individual domain scores and ranges from 0 to 18. Higher scores indicate more clinical impairment. Negative changes at post tDCS compared to baseline represent an improvement on the scale.
Measured: Baseline, post tDCS (week 3)
Change in Behavioral Symptom Severity (NPI)
The Neuropsychiatric Inventory (NPI) is a behavioral scale administered to the caregiver assessing 12 dimensions: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor activity, nighttime behaviors, and appetite/eating. Each dimension has multiple screening questions relating to symptoms. If the answer to the screening questions is "Yes", the dimensional-score is the product of frequency (1=occasionally to 4=very frequently) and severity (1=Mild to 3=Severe) of symptoms. Dimensional-scores are summed (from 0 to 144). Higher scores indicate greater behavioral disturbances. Negative changes at post tDCS compared to baseline represent an improvement on the scale.
Measured: Baseline, post tDCS (week 3)
Change in Behavioral Symptom Severity (FBI)
The Frontal Behavioral Inventory (FBI) is a 24-item inventory designed to assess behavior and personality changes via caregiver. Item-level scores range from 0=none, 1=mild/occasional, 2=moderate, 3=severe/most of the time. Item-scores are summed (from 0 to 72). Higher scores indicate greater behavioral/personality disturbances. Negative changes at post tDCS compared to baseline represent an improvement on the scale.
Measured: Baseline, post tDCS (week 3)
Change in Functional Connectivity
Default mode network (DMN) and salience network (SN) mean functional connectivity is assessed on resting state functional MRI. Functional connectivity is standardized to Z scores and thresholded at Z>2. Higher values denote greater functional connectivity. A positive change at post tDCS compared to baseline represents an increase in resting-state functional connectivity.
Measured: Baseline, post tDCS (week 3)
Change in Cerebral Blood Flow
Default mode network (DMN) and salience network (SN) mean cerebral blood flow is assessed on arterial spin labeling. Cerebral blood flow is computed by averaging values across the DMN and SN regions of interest. Cerebral blood flow is a measure of brain perfusion, higher values denoting higher perfusion. A positive change at post tDCS compared to baseline represents an increase in perfusion.
Measured: Baseline, post tDCS (week 3)
Secondary outcomes (7)
Change in Cognition: Memory
The composite memory score consists of the averaged Z-standardized scores of 5 memory tests: immediate and delayed auditory verbal learning test recall, Rey-Osterrieth complex figure recall, story recall, digit span backward and forward tests. Each test score is normalized to an independent dataset of healthy controls. Z-scores have no minimum/maximum values. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values denote better memory performance. Positive changes at post tDCS compared to baseline represent an improvement in memory.
Measured: Baseline, post tDCS (week 3)
Change in Cognition: Language
The composite language score consists of the averaged Z-standardized scores of 2 language tests: verbal fluency and token tests. Each test score is normalized to an independent dataset of healthy controls. Z-scores have no minimum/maximum values. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values denote better language performance. Positive changes at post tDCS compared to baseline represent an improvement in language.
Measured: Baseline, post tDCS (week 3)
Change in Cognition: Executive Function
The composite executive function score consists of the averaged Z-standardized scores of 2 executive functions tests: trail making test part A and part B tests. Each test score is normalized to an independent dataset of healthy controls and inverted. Z-scores have no minimum/maximum values. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values denote better executive function performance. Positive changes at post tDCS compared to baseline represent an improvement in executive functions.
Measured: Baseline, post tDCS (week 3)
Change in Cognition: Visuospatial Function
The visuospatial function score consists of the Z-standardized scores for the Rey-Osterrieth complex figure copy test. Scores are normalized to an independent dataset of healthy controls. Z-scores have no minimum/maximum values. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values denote better visuospatial performance. Positive changes at post tDCS compared to baseline represent an improvement in visuospatial functions.
Measured: Baseline, post tDCS (week 3)
Change in Cognition: Emotion Recognition
The composite emotion recognition score consists of the averaged Z-standardized scores for 2 emotion recognition tests: reading the Mind in the Eyes and 60 Ekman faces tests. Each test score is normalized to an independent dataset of healthy controls. Z-scores have no minimum/maximum values. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values denote better emotion recognition performance. Positive changes at post tDCS compared to baseline represent an improvement in emotion recognition.
Measured: Baseline, post tDCS (week 3)
Change in Structural Connectivity: FA
Fractional anisotropy (FA) is assessed on diffusion weighted imaging. FA values are averaged in default mode network (DMN) and salience network (SN) regions of interest. FA values denote the directionality of water diffusivity, ranging from 0 (isotropic diffusion) to 1 (anisotropic diffusion). Higher values denote higher directionality and connectivity. Positive changes at post tDCS compared to baseline represent an improvement in the measure.
Measured: Baseline, post tDCS (week 3)
Change in Structural Connectivity: MD, AxD, RaD
Mean diffusivity (MD), axial diffusivity (AxD), and radial diffusivity (RaD) are assessed on diffusion weighted imaging. MD, AxD, RaD values are averaged in default mode network (DMN) and salience network (SN) regions of interest. MD, AxD, and RaD measure water diffusion and are expressed in mm^2/s (starting from 0 with no maximum value; scaled at x10^-3). Higher values denote higher diffusion and lower connectivity. Negative changes at post tDCS compared to baseline represent an improvement in the measure.
Measured: Baseline, post tDCS (week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start8 Jun 2015
- Primary completion3 Nov 2018
- Study completion3 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michela Pievani, IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Investigators
- Michela Pievani, PhD, Principal investigator, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422250
- Sponsor's protocol ID
- GR-2011-02349787
- Acronym
- NetCogBs
- Status last verified
- Apr 2021
- First submitted
- 16 Jan 2018
- Last updated
- 19 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pievani M, Pini L, Cappa SF, Frisoni GB. Brain networks stimulation in dementia: insights from functional imaging. Curr Opin Neurol. 2016 Dec;29(6):756-762. doi: 10.1097/WCO.0000000000000387.
PubMed 27661207Pini L, Pizzini FB, Boscolo-Galazzo I, Ferrari C, Galluzzi S, Cotelli M, Gobbi E, Cattaneo A, Cotelli MS, Geroldi C, Zanetti O, Corbetta M, van den Heuvel M, Frisoni GB, Manenti R, Pievani M. Brain network modulation in Alzheimer's and frontotemporal dementia with transcranial electrical stimulation. Neurobiol Aging. 2022 Mar;111:24-34. doi: 10.1016/j.neurobiolaging.2021.11.005. Epub 2021 Nov 20.
PubMed 34942516
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-invasive, Multimodal Approach to Restore Functional Networks and Cognition in Alzheimer's Disease and Frontotemporal Dementia
- ClinicalTrials.gov ID
- NCT03422250
- Acronym / sponsor ID
- NetCogBs / GR-2011-02349787
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
- Study start
- 8 Jun 2015 (actual)
- Primary completion
- 3 Nov 2018 (actual)
- Study completion
- 3 Nov 2018 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Posted 29 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: transcranial direct current stimulation (tDCS)Alzheimer's disease (AD): anodal tDCS of the default mode network (DMN) |
| Arm 2 | Experimental | Device: transcranial direct current stimulation (tDCS)Alzheimer's disease (AD): cathodal tDCS of the salience network (SN) |
| Arm 3 | Experimental | Device: transcranial direct current stimulation (tDCS)Behavioral-variant frontotemporal dementia (bvFTD): anodal tDCS of the salience network (SN) |
| Arm 4 | Experimental | Device: transcranial direct current stimulation (tDCS)Behavioral-variant frontotemporal dementia (bvFTD): cathodal tDCS of the default mode network (DMN) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Moderate/severe dementia
- Presence of any medical or psychiatric illness that could interfere in completing assessments
- metal implants, pace-makers, prosthetic heart valves
- claustrophobia
- history of epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulation (tDCS)10 daily 25-minutes tDCS sessions over two weeks. | Device | Arm 1, Arm 2, Arm 3, Arm 4 |
Primary outcome
Change in Clinical Disease Severity (CDR)
Time frame: Baseline, post tDCS (week 3)
CDR - Clinical Dementia Rating score The clinical dementia rating (CDR) is a clinical global rating scale administered to both the participant and the caregiver, assessing 6 domains of participant function: memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care. Each domain is based on a 5-point scale ranging from no impairment=0, questionable impairment=0.5, mild impairment=1, moderate impairment=2 to severe impairment=3. The global CDR score is computed via a memory-weighted averaging algorithm of the six domain scores and ranges from 0 to 5. The CDR-sum of boxes (CDR-SB) is the sum of the individual domain scores and ranges from 0 to 18. Higher scores indicate more clinical impairment. Negative changes at post tDCS compared to baseline represent an improvement on the scale.
Change in Behavioral Symptom Severity (NPI)
Time frame: Baseline, post tDCS (week 3)
The Neuropsychiatric Inventory (NPI) is a behavioral scale administered to the caregiver assessing 12 dimensions: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor activity, nighttime behaviors, and appetite/eating. Each dimension has multiple screening questions relating to symptoms. If the answer to the screening questions is "Yes", the dimensional-score is the product of frequency (1=occasionally to 4=very frequently) and severity (1=Mild to 3=Severe) of symptoms. Dimensional-scores are summed (from 0 to 144). Higher scores indicate greater behavioral disturbances. Negative changes at post tDCS compared to baseline represent an improvement on the scale.
Change in Behavioral Symptom Severity (FBI)
Time frame: Baseline, post tDCS (week 3)
The Frontal Behavioral Inventory (FBI) is a 24-item inventory designed to assess behavior and personality changes via caregiver. Item-level scores range from 0=none, 1=mild/occasional, 2=moderate, 3=severe/most of the time. Item-scores are summed (from 0 to 72). Higher scores indicate greater behavioral/personality disturbances. Negative changes at post tDCS compared to baseline represent an improvement on the scale.
Change in Functional Connectivity
Time frame: Baseline, post tDCS (week 3)
Default mode network (DMN) and salience network (SN) mean functional connectivity is assessed on resting state functional MRI. Functional connectivity is standardized to Z scores and thresholded at Z>2. Higher values denote greater functional connectivity. A positive change at post tDCS compared to baseline represents an increase in resting-state functional connectivity.
Change in Cerebral Blood Flow
Time frame: Baseline, post tDCS (week 3)
Default mode network (DMN) and salience network (SN) mean cerebral blood flow is assessed on arterial spin labeling. Cerebral blood flow is computed by averaging values across the DMN and SN regions of interest. Cerebral blood flow is a measure of brain perfusion, higher values denoting higher perfusion. A positive change at post tDCS compared to baseline represents an increase in perfusion.
7 secondary outcomes
Change in Cognition: Memory
Time frame: Baseline, post tDCS (week 3)
Change in Cognition: Language
Time frame: Baseline, post tDCS (week 3)
Change in Cognition: Executive Function
Time frame: Baseline, post tDCS (week 3)
Change in Cognition: Visuospatial Function
Time frame: Baseline, post tDCS (week 3)
Change in Cognition: Emotion Recognition
Time frame: Baseline, post tDCS (week 3)
Change in Structural Connectivity: FA
Time frame: Baseline, post tDCS (week 3)
Change in Structural Connectivity: MD, AxD, RaD
Time frame: Baseline, post tDCS (week 3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27661207Pievani M, Pini L, Cappa SF, Frisoni GB. Brain networks stimulation in dementia: insights from functional imaging. Curr Opin Neurol. 2016 Dec;29(6):756-762. doi: 10.1097/WCO.0000000000000387.
- Derived from this study: PubMed 34942516Pini L, Pizzini FB, Boscolo-Galazzo I, Ferrari C, Galluzzi S, Cotelli M, Gobbi E, Cattaneo A, Cotelli MS, Geroldi C, Zanetti O, Corbetta M, van den Heuvel M, Frisoni GB, Manenti R, Pievani M. Brain network modulation in Alzheimer's and frontotemporal dementia with transcranial electrical stimulation. Neurobiol Aging. 2022 Mar;111:24-34. doi: 10.1016/j.neurobiolaging.2021.11.005. Epub 2021 Nov 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michela Pievani, PhD principal investigator
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation (tDCS) in people with Alzheimer's Disease and Frontotemporal Dementia, Behavioral Variant, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Disease Severity (CDR) (time frame: Baseline, post tDCS (week 3)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03422250, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.