Neurostimulation and Cognitive Intervention in Alzheimer's Disease (NeuroAD)
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ClinicalTrials.gov Identifier: NCT02772185 |
Recruitment Status : Unknown
Verified May 2016 by Suellen Marinho Andrade, Federal University of Paraíba.
Recruitment status was: Recruiting
First Posted : May 13, 2016
Last Update Posted : May 13, 2016
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Condition or disease | Intervention/treatment | Phase |
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Alzheimer's Disease | Device: active tDCS Device: sham tDCS Behavioral: real CT Behavioral: placebo CT | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Neurostimulation and Cognitive Intervention in Alzheimer's Disease |
Study Start Date : | May 2016 |
Estimated Primary Completion Date : | May 2018 |
Estimated Study Completion Date : | May 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: active tDCS plus real CT
Participants will receive active transcranial direct current stimulation and real cognitive training.
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Device: active tDCS
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 Behavioral: real CT 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). |
Experimental: sham tDCS plus real CT
Participants will receive sham transcranial direct current stimulation and real cognitive training.
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Device: sham tDCS
The procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham. Behavioral: real CT 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). |
Experimental: active tDCS plus placebo CT
Participants will receive active transcranial direct current stimulation and placebo cognitive training.
|
Device: active tDCS
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 Behavioral: placebo CT Videos (short films) will be presented during the neurostimulation |
Placebo Comparator: sham tDCS plus placebo CT
Participants will receive sham transcranial direct current stimulation and placebo cognitive training.
|
Device: sham tDCS
The procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham. Behavioral: placebo CT Videos (short films) will be presented during the neurostimulation |
- 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) ]
- 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 ]

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Ages Eligible for Study: | 60 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772185
Contact: Suellen M Andrade, PhD | suellenandrade@gmail.com |
Brazil | |
Suellen Andrade | Recruiting |
João Pessoa, PB, Brazil | |
Contact: Suellen Andrade | |
Contact suellenandrade@gmail.com |
Responsible Party: | Suellen Marinho Andrade, Professor, Federal University of Paraíba |
ClinicalTrials.gov Identifier: | NCT02772185 |
Other Study ID Numbers: |
NeuroAD |
First Posted: | May 13, 2016 Key Record Dates |
Last Update Posted: | May 13, 2016 |
Last Verified: | May 2016 |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |