Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active tDCS plus real CT | Experimental | Participants will receive active transcranial direct current stimulation and real cognitive training. |
|
| sham tDCS plus real CT | Experimental | Participants will receive sham transcranial direct current stimulation and real cognitive training. |
|
| active tDCS plus placebo CT | Experimental | Participants will receive active transcranial direct current stimulation and placebo cognitive training. |
|
| sham tDCS plus placebo CT | Placebo Comparator | Participants will receive sham transcranial direct current stimulation and placebo cognitive training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active tDCS | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive function assessed on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) | Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive ability assessed on the Wechsler Adult Intelligence Scale | 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 | Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suellen M Andrade, PhD | Contact | suellenandrade@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suellen Andrade | Recruiting | João Pessoa | ParaÃba | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42032764 | Derived | 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. | |
| 37859768 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| sham tDCS | Device | The procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham. |
|
| real CT | Behavioral | 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 CT | Behavioral | Videos (short films) will be presented during the neurostimulation |
|
| Change in verbal working memory assessed on the Digit Span task | 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 | 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 | 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 | Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months) |
| Change in functional ability assessed on the Disability Assessment Dementia | 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 | 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 | 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 | 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) | Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months) |
| Side Effects Questionnaire | From date of first neurostimulation until the date of last neurostimulation, assessed up to 12 months |
| Andrade 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. |
| 33883015 | Derived | Marchi 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. |
| 30450044 | Derived | Andrade 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. |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |