Alzheimer's DiseasePhase 2/3NeuroADNCT02772185
Neurostimulation and Cognitive Intervention in Alzheimer's Disease
A Phase 2/3 study testing active tDCS and real CT in people with Alzheimer's Disease, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
This study is a double blind, sham-controlled clinical trial aiming to compare the long-term effects of stimulation in Alzheimer's Disease (AD). Sixty early AD patients will take part in a phase II/III clinical study over a 1-year period. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- active tDCS and real CT
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- May 2016to May 2019
- Phase
- Phase 2/3
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age 60-90 years
- Patients diagnosed with Alzheimer's Disease, according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) and NINCDS-ADRDA (National Institute for Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association) criteria
- Score between 18 and 26 on the Mini Mental State Examination
- Have a CDR (Clinical Dementia Rating) of 1.0
- If medicated for AD, then use of cholinesterase inhibitors, for at least 3 months and on stable dose for at least 60 days prior to screening.
Who cannot join
- Pre-existing structural brain abnormalities,
- Other neurologic or psychiatric diagnoses
- Transcranial direct current stimulation criteria: patients with implanted metallic or electronic devices; pacemaker; seizures; pregnancy; any other condition that might limit or interfere in the sensorimotor system
Trial locations and contacts
1 site in 1 country.
Suellen M Andrade, PhD contact
Brazil1 site, 1 recruiting
- Recruiting
Suellen Andrade
João Pessoa, Paraíba
Suellen Andrade
suellenandrade@gmail.com
About this study
This study is a double blind, sham-controlled clinical trial aiming to compare the long-term effects of stimulation in Alzheimer's Disease (AD). Sixty early AD patients will take part in a phase II/III clinical study over a 1-year period. The study involves transcranial direct current stimulation (tDCS), cognitive training (CT), detailed neuropsychological and neurological testing. These assessments will occur at baseline, then again at two month (end point). Those who achieve clinical improvement with neurostimulation and cognitive therapy will be invited to receive treatment for 12 months as part of a follow-up study.
Read the detailed description
The patients will be randomized into 1 of 4 groups: active tDCS plus real CT, active tDCS plus placebo CT, sham tDCS plus real CT, sham tDCS plus placebo CT. Each group will receive treatment for 30 minutes a day, 3 days a week for 8 weeks.
- Conditions
- Alzheimer's Disease
- Being tested
- active tDCS, sham tDCS, real CT, placebo CT
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active tDCSDevice
Duration: 30 minutes; Intensity: 2 mA; Placement:left and right parietal cortex, left and right DLPFC, left inferior frontal gyrus and left superior temporal gyrus
sham tDCSDevice
The procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham.
real CTBehavioural
Cognitive tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left inferior frontal gyrus and left superior temporal gyrus).
placebo CTBehavioural
Videos (short films) will be presented during the neurostimulation
| Study group | Role | What they receive |
|---|---|---|
| active tDCS plus real CT | Experimental | Participants will receive active transcranial direct current stimulation and real cognitive training. Receives: Device: active tDCS; Behavioral: real CT |
| sham tDCS plus real CT | Experimental | Participants will receive sham transcranial direct current stimulation and real cognitive training. Receives: Device: sham tDCS; Behavioral: real CT |
| active tDCS plus placebo CT | Experimental | Participants will receive active transcranial direct current stimulation and placebo cognitive training. Receives: Device: active tDCS; Behavioral: placebo CT |
| sham tDCS plus placebo CT | Placebo comparator | Participants will receive sham transcranial direct current stimulation and placebo cognitive training. Receives: Device: sham tDCS; Behavioral: placebo CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive function assessed on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)
Measured: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Secondary outcomes (12)
Change in cognitive ability assessed on the Wechsler Adult Intelligence Scale
Measured: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in visuo-spatial working memory assessed on the Corsi block task
Measured: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in verbal working memory assessed on the Digit Span task
Measured: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in speed of cognitive processing and executive functioning assessed on the Trail Making Test
Measured: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in executive function assessed on the Stroop Color and Word Test
Measured: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in verbal fluency assessed on the FAS Verbal Fluency Test
Measured: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in functional ability assessed on the Disability Assessment Dementia
Measured: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in visual recognition assessed on the Poppelreuter-Ghent's Overlapping Figures test
Measured: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in behavioral and psychological disturbances assessed on the Neuropsychiatric Inventory Questionnaire
Measured: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in subjective burden among caregivers assessed on the Zarit Burden Interview
Measured: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in electrical activity of the brain assessed on the Electroencephalogram (EEG)
Measured: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Side Effects Questionnaire
Measured: From date of first neurostimulation until the date of last neurostimulation, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2018 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suellen Marinho Andrade, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772185
- Sponsor's protocol ID
- NeuroAD
- Acronym
- NeuroAD
- Status last verified
- May 2016
- First submitted
- 5 May 2016
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Alexandrino KALG, de Aquino AMI, de Melo SD, de Andrade Cesar MB, Motta AR, Weller M, Galisa SLG, de Faria JR, Dos Santos Andrade SMM. Effects of transcranial direct current stimulation on cognition, depression, and brain activity in a breast-cancer survivor: a case report. J Med Case Rep. 2026 Apr 25;20(1):319. doi: 10.1186/s13256-026-06061-4.
PubMed 42032764Andrade SM, da Silva-Sauer L, de Carvalho CD, de Araujo ELM, Lima EO, Fernandes FML, Moreira KLAF, Camilo ME, Andrade LMMDS, Borges DT, da Silva Filho EM, Lindquist AR, Pegado R, Morya E, Yamauti SY, Alves NT, Fernandez-Calvo B, de Souza Neto JMR. Identifying biomarkers for tDCS treatment response in Alzheimer's disease patients: a machine learning approach using resting-state EEG classification. Front Hum Neurosci. 2023 Oct 4;17:1234168. doi: 10.3389/fnhum.2023.1234168. eCollection 2023.
PubMed 37859768Marchi LZ, Ferreira RGD, de Lima GNS, da Silva JAS, da Cruz DMC, Fernandez-Calvo B, Andrade SMMDS. Multisite transcranial direct current stimulation associated with cognitive training in episodic memory and executive functions in individuals with Alzheimer's disease: a case report. J Med Case Rep. 2021 Apr 22;15(1):185. doi: 10.1186/s13256-021-02800-x.
PubMed 33883015Andrade SM, de Oliveira EA, Alves NT, Dos Santos ACG, de Mendonca CTPL, Sampaio DDA, da Silva EEQC, da Fonseca EKG, de Almeida Rodrigues ET, de Lima GNS, Carvalho J, da Silva JAS, Toledo M, da Rosa MRD, Gomes MQC, de Oliveira MM, Lemos MTM, Lima NG, Inacio P, da Cruz Ribeiro E Rodrigues PM, Ferreira RGD, Cavalcante R, de Brito Aranha REL, Neves R, da Costa E Souza RM, Portugal TM, Martins WKN, Pontes V, de Paiva Fernandes TM, Contador I, Fernandez-Calvo B. Neurostimulation Combined With Cognitive Intervention in Alzheimer's Disease (NeuroAD): Study Protocol of Double-Blind, Randomized, Factorial Clinical Trial. Front Aging Neurosci. 2018 Nov 2;10:334. doi: 10.3389/fnagi.2018.00334. eCollection 2018.
PubMed 30450044
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurostimulation and Cognitive Intervention in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02772185
- Acronym / sponsor ID
- NeuroAD / NeuroAD
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 13 May 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.
This study is a double blind, sham-controlled clinical trial aiming to compare the long-term effects of stimulation in Alzheimer's Disease (AD). Sixty early AD patients will take part in a phase II/III clinical study over a 1-year period. The study involves transcranial direct current stimulation (tDCS), cognitive training (CT), detailed neuropsychological and neurological testing. These assessments will occur at baseline, then again at two month (end point). Those who achieve clinical improvement with neurostimulation and cognitive therapy will be invited to receive treatment for 12 months as part of a follow-up study.
Detailed description
The patients will be randomized into 1 of 4 groups: active tDCS plus real CT, active tDCS plus placebo CT, sham tDCS plus real CT, sham tDCS plus placebo CT. Each group will receive treatment for 30 minutes a day, 3 days a week for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| active tDCS plus real CT | Experimental | Device: active tDCS, Behavioral: real CTParticipants will receive active transcranial direct current stimulation and real cognitive training. |
| sham tDCS plus real CT | Experimental | Device: sham tDCS, Behavioral: real CTParticipants will receive sham transcranial direct current stimulation and real cognitive training. |
| active tDCS plus placebo CT | Experimental | Device: active tDCS, Behavioral: placebo CTParticipants will receive active transcranial direct current stimulation and placebo cognitive training. |
| sham tDCS plus placebo CT | Placebo comparator | Device: sham tDCS, Behavioral: placebo CTParticipants will receive sham transcranial direct current stimulation and placebo cognitive training. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female age 60-90 years
- Patients diagnosed with Alzheimer's Disease, according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) and NINCDS-ADRDA (National Institute for Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association) criteria
- Score between 18 and 26 on the Mini Mental State Examination
- Have a CDR (Clinical Dementia Rating) of 1.0
- If medicated for AD, then use of cholinesterase inhibitors, for at least 3 months and on stable dose for at least 60 days prior to screening.
Key exclusion criteria (3 listed)
- Pre-existing structural brain abnormalities,
- Other neurologic or psychiatric diagnoses
- Transcranial direct current stimulation criteria: patients with implanted metallic or electronic devices; pacemaker; seizures; pregnancy; any other condition that might limit or interfere in the sensorimotor system
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 |
|---|---|---|
| active tDCSDuration: 30 minutes; Intensity: 2 mA; Placement:left and right parietal cortex, left and right DLPFC, left inferior frontal gyrus and left superior temporal gyrus | Device | active tDCS plus placebo CT, active tDCS plus real CT |
| sham tDCSThe procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham. | Device | sham tDCS plus placebo CT, sham tDCS plus real CT |
| real CTCognitive tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left inferior frontal gyrus and left superior temporal gyrus). | Behavioural | active tDCS plus real CT, sham tDCS plus real CT |
| placebo CTVideos (short films) will be presented during the neurostimulation | Behavioural | active tDCS plus placebo CT, sham tDCS plus placebo CT |
Primary outcome
Change in cognitive function assessed on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
12 secondary outcomes
Change in cognitive ability assessed on the Wechsler Adult Intelligence Scale
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in visuo-spatial working memory assessed on the Corsi block task
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in verbal working memory assessed on the Digit Span task
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in speed of cognitive processing and executive functioning assessed on the Trail Making Test
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in executive function assessed on the Stroop Color and Word Test
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in verbal fluency assessed on the FAS Verbal Fluency Test
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in functional ability assessed on the Disability Assessment Dementia
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in visual recognition assessed on the Poppelreuter-Ghent's Overlapping Figures test
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in behavioral and psychological disturbances assessed on the Neuropsychiatric Inventory Questionnaire
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in subjective burden among caregivers assessed on the Zarit Burden Interview
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in electrical activity of the brain assessed on the Electroencephalogram (EEG)
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Side Effects Questionnaire
Time frame: From date of first neurostimulation until the date of last neurostimulation, assessed up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Derived from this study: PubMed 42032764Alexandrino KALG, de Aquino AMI, de Melo SD, de Andrade Cesar MB, Motta AR, Weller M, Galisa SLG, de Faria JR, Dos Santos Andrade SMM. Effects of transcranial direct current stimulation on cognition, depression, and brain activity in a breast-cancer survivor: a case report. J Med Case Rep. 2026 Apr 25;20(1):319. doi: 10.1186/s13256-026-06061-4.
- Derived from this study: PubMed 37859768Andrade SM, da Silva-Sauer L, de Carvalho CD, de Araujo ELM, Lima EO, Fernandes FML, Moreira KLAF, Camilo ME, Andrade LMMDS, Borges DT, da Silva Filho EM, Lindquist AR, Pegado R, Morya E, Yamauti SY, Alves NT, Fernandez-Calvo B, de Souza Neto JMR. Identifying biomarkers for tDCS treatment response in Alzheimer's disease patients: a machine learning approach using resting-state EEG classification. Front Hum Neurosci. 2023 Oct 4;17:1234168. doi: 10.3389/fnhum.2023.1234168. eCollection 2023.
- Derived from this study: PubMed 33883015Marchi LZ, Ferreira RGD, de Lima GNS, da Silva JAS, da Cruz DMC, Fernandez-Calvo B, Andrade SMMDS. Multisite transcranial direct current stimulation associated with cognitive training in episodic memory and executive functions in individuals with Alzheimer's disease: a case report. J Med Case Rep. 2021 Apr 22;15(1):185. doi: 10.1186/s13256-021-02800-x.
- Derived from this study: PubMed 30450044Andrade SM, de Oliveira EA, Alves NT, Dos Santos ACG, de Mendonca CTPL, Sampaio DDA, da Silva EEQC, da Fonseca EKG, de Almeida Rodrigues ET, de Lima GNS, Carvalho J, da Silva JAS, Toledo M, da Rosa MRD, Gomes MQC, de Oliveira MM, Lemos MTM, Lima NG, Inacio P, da Cruz Ribeiro E Rodrigues PM, Ferreira RGD, Cavalcante R, de Brito Aranha REL, Neves R, da Costa E Souza RM, Portugal TM, Martins WKN, Pontes V, de Paiva Fernandes TM, Contador I, Fernandez-Calvo B. Neurostimulation Combined With Cognitive Intervention in Alzheimer's Disease (NeuroAD): Study Protocol of Double-Blind, Randomized, Factorial Clinical Trial. Front Aging Neurosci. 2018 Nov 2;10:334. doi: 10.3389/fnagi.2018.00334. eCollection 2018.
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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.
Suellen M Andrade, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing active tDCS and real CT in people with Alzheimer's Disease, run by Federal University of Paraíba at 1 site in Brazil.
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 3 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 May 2016. 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 Brazil. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Suellen M Andrade, PhD (suellenandrade@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive function assessed on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) (time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)). 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 NCT02772185, which also lists 4 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 13 May 2016.