Alzheimer's DiseaseALSTICONCT02873546
tDCS Effect on Cognitive Functions From Patients With Alzheimer's Disease or Progressive Primary Aphasia
A study testing transcranial Direct Current Stimulation (tDCS) in people with Alzheimer's Disease and Progressive Primary Aphasia, run by Centre Hospitalier Universitaire de Besancon at 3 sites in France.
Trial summary
The purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial Direct Current Stimulation (tDCS - 1 mA) applied to left Cortex DorsoLateral PreFrontal (CDLPF) of Alzheimer's or Primary Progressive Aphasia (PPA) patients compared to the application of a placebo tDCS (sham procedure) on… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer's Disease, Progressive Primary Aphasia, Early or Mild State
- What is being tested?
- transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 3 sitesFrance
- Study dates
- 19 Jul 2013to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRADA) criteria (Alzheimer's patient) OR Gordo-Tempini criteria (PPA's patient)
- CDR score ≤ 2
- treatment by IAChE ≥ 3 months
- MADRS score < 18
- w/o severe progressive somatic pathology (especially tumor diseases)
Who cannot join
- last neuropsychological assessment < 6 months
- presence of a specific contraindication for tDCS (e.g. personal history of epilepsy, metallic head implant, cardiac pacemaker)
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
CHU Besancon - Clinical Psychiatric Department
Besançon, 25000
Magali Nicolier, PhD, +33381219007, mnicolier@chu-besancon.fr
Pierre Vandel, MD PhD
- Not yet recruiting
Hopital Universitaire Dijon
Dijon
Bernard Bonnin, MD PhD
Bernard Bonnin, MD PhD
- Recruiting
Assistance Publique - Hôpitaux Paris
Paris
Hélène Francisque, +33140054390, helene.francisque@gmail.com
Hélène Francisque
About this study
Official title: Evaluation de l'Effet de la tDCS Sur Les Fonctions Cognitives de Patients Souffrant de Maladie d'Alzheimer et Maladies apparentées au Stade léger
The purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial Direct Current Stimulation (tDCS - 1 mA) applied to left Cortex DorsoLateral PreFrontal (CDLPF) of Alzheimer's or Primary Progressive Aphasia (PPA) patients compared to the application of a placebo tDCS (sham procedure) on cognitive functions, which are evaluated at short term (1 week post-treatment) and mild term (3 weeks post-treatment).
After unblinding, patients who received placebo treatment could be received active tDCS.
- 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
Also called EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Germany)
After locating the stimulation areas, treatment will be delivered during 30-minute session. Treatment will be occur 2 session per day during 5 consecutive days. Subjects will be monitored during tDCS sessions for any side effects or adverse events.
| Study group | Role | What they receive |
|---|---|---|
| anodal tDCS on left DLPFC (F3) | Active comparator | tDCS is a non-invasive neuromodulation method, which delivers a constant current of low intensity (1 mA) during 30 minutes for 10 sessions. Anode is placed on the scalp facing on left DLPFC (F3) and cathode between Fp2-F8 EEG-repair. Receives: Device: transcranial Direct Current Stimulation (tDCS) |
| sham tDCS on left DLPFC (F3) | Sham comparator | Sham tDCS differs from active tDCS by the interruption of stimulation after 15 sec and reactivation of the stimulation 15 sec before the end of the session (30 minutes - 10 sessions. Anode is placed on the scalp facing on left DLPFC (F3) and cathode between Fp2-F8 EEG-repair. 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 from baseline cognitive functions at 3 weeks
neuropsychological assessments include Rapid battery tests (Bereay et al., 2015)
Measured: baseline, day 5 and 3 weeks post-tDCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start19 Jul 2013
- Primary completion31 Jan 2018 (estimated)
- Study completion31 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Paquet, MD PhD, Principal investigator, Assitance Publique - Hôpitaux ParisBernard Bonnin, MD PhD, Principal investigator, Centre Hospitalier Universaitaire Dijon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873546
- Sponsor's protocol ID
- API/2011/24
- Acronym
- ALSTICO
- Status last verified
- Oct 2017
- First submitted
- 11 Aug 2016
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bereau M, Sylvestre G, Mauny F, Puyraveau M, Baudier F, Magnin E, Berger E, Vandel P, Galmiche J, Chopard G. [Assessment of 10 years of memory consultations in the Franche-Comte: Description and analysis of the RAPID regional database]. Rev Neurol (Paris). 2015 Sep;171(8-9):655-61. doi: 10.1016/j.neurol.2015.04.008. Epub 2015 Jul 23. French.
PubMed 26212200
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation de l'Effet de la tDCS Sur Les Fonctions Cognitives de Patients Souffrant de Maladie d'Alzheimer et Maladies apparentées au Stade léger
- ClinicalTrials.gov ID
- NCT02873546
- Acronym / sponsor ID
- ALSTICO / API/2011/24
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Dijon, Assistance Publique - Hôpitaux de Paris
- Study start
- 19 Jul 2013 (actual)
- Primary completion
- 31 Jan 2018 (estimated)
- Study completion
- 31 Jul 2018 (estimated)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial Direct Current Stimulation (tDCS - 1 mA) applied to left Cortex DorsoLateral PreFrontal (CDLPF) of Alzheimer's or Primary Progressive Aphasia (PPA) patients compared to the application of a placebo tDCS (sham procedure) on cognitive functions, which are evaluated at short term (1 week post-treatment) and mild term (3 weeks post-treatment).
After unblinding, patients who received placebo treatment could be received active tDCS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anodal tDCS on left DLPFC (F3) | Active comparator | Device: transcranial Direct Current Stimulation (tDCS)tDCS is a non-invasive neuromodulation method, which delivers a constant current of low intensity (1 mA) during 30 minutes for 10 sessions. Anode is placed on the scalp facing on left DLPFC (F3) and cathode between Fp2-F8 EEG-repair. |
| sham tDCS on left DLPFC (F3) | Sham comparator | Device: transcranial Direct Current Stimulation (tDCS)Sham tDCS differs from active tDCS by the interruption of stimulation after 15 sec and reactivation of the stimulation 15 sec before the end of the session (30 minutes - 10 sessions. Anode is placed on the scalp facing on left DLPFC (F3) and cathode between Fp2-F8 EEG-repair. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRADA) criteria (Alzheimer's patient) OR Gordo-Tempini criteria (PPA's patient)
- CDR score ≤ 2
- treatment by IAChE ≥ 3 months
- MADRS score < 18
- w/o severe progressive somatic pathology (especially tumor diseases)
Key exclusion criteria (2 listed)
- last neuropsychological assessment < 6 months
- presence of a specific contraindication for tDCS (e.g. personal history of epilepsy, metallic head implant, cardiac pacemaker)
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)Also: EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Germany)After locating the stimulation areas, treatment will be delivered during 30-minute session. Treatment will be occur 2 session per day during 5 consecutive days. Subjects will be monitored during tDCS sessions for any side effects or adverse events. | Device | anodal tDCS on left DLPFC (F3), sham tDCS on left DLPFC (F3) |
Primary outcome
change from baseline cognitive functions at 3 weeks
Time frame: baseline, day 5 and 3 weeks post-tDCS
neuropsychological assessments include Rapid battery tests (Bereay et al., 2015)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Background: PubMed 26212200Bereau M, Sylvestre G, Mauny F, Puyraveau M, Baudier F, Magnin E, Berger E, Vandel P, Galmiche J, Chopard G. [Assessment of 10 years of memory consultations in the Franche-Comte: Description and analysis of the RAPID regional database]. Rev Neurol (Paris). 2015 Sep;171(8-9):655-61. doi: 10.1016/j.neurol.2015.04.008. Epub 2015 Jul 23. French.
- Individual participant dataSharing planned: No
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
Claire Paquet, MD PhD principal investigator
Assitance Publique - Hôpitaux Paris
Bernard Bonnin, MD PhD principal investigator
Centre Hospitalier Universaitaire Dijon
3 sites 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 Progressive Primary Aphasia, run by Centre Hospitalier Universitaire de Besancon at 3 sites in France.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Vandel, MD PhD (+33381219007, pierre.vandel@univ-fcomte.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline cognitive functions at 3 weeks (time frame: baseline, day 5 and 3 weeks post-tDCS). 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 NCT02873546, which also lists 1 linked publication.
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 13 Oct 2017.