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Neurostimulation and Cognitive Intervention in Alzheimer's Disease (NeuroAD)

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ClinicalTrials.gov Identifier: NCT02772185
Recruitment Status : Recruiting
First Posted : May 13, 2016
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Device: active tDCS Device: sham tDCS Behavioral: real CT Behavioral: placebo CT Phase 2 Phase 3

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

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: active tDCS plus real CT
Participants will receive active transcranial direct current stimulation and real 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: 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.
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


Outcome Measures

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. 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) ]
  8. 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) ]
  9. 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) ]
  10. 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) ]
  11. 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) ]
  12. Side Effects Questionnaire [ Time Frame: From date of first neurostimulation until the date of last neurostimulation, assessed up to 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: Suellen M Andrade, PhD suellenandrade@gmail.com

Locations
Brazil
Suellen Andrade Recruiting
João Pessoa, PB, Brazil
Contact: Suellen Andrade         
Contact       suellenandrade@gmail.com   
Sponsors and Collaborators
Federal University of Paraíba
More Information

Responsible Party: Suellen Marinho Andrade, Professor, Federal University of Paraíba
ClinicalTrials.gov Identifier: NCT02772185     History of Changes
Other Study ID Numbers: NeuroAD
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders