Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Suellen Marinho Andrade, Federal University of Paraíba

Tracking Information
First Submitted Date  ICMJE May 5, 2016
First Posted Date  ICMJE May 13, 2016
Last Update Posted Date May 13, 2016
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neurostimulation and Cognitive Intervention in Alzheimer's Disease
Official Title  ICMJE Neurostimulation and Cognitive Intervention in Alzheimer's Disease
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • 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
  • 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).
  • Behavioral: placebo CT
    Videos (short films) will be presented during the neurostimulation
Study Arms  ICMJE
  • Experimental: active tDCS plus real CT
    Participants will receive active transcranial direct current stimulation and real cognitive training.
    Interventions:
    • Device: active tDCS
    • Behavioral: real CT
  • Experimental: sham tDCS plus real CT
    Participants will receive sham transcranial direct current stimulation and real cognitive training.
    Interventions:
    • Device: sham tDCS
    • Behavioral: real CT
  • Experimental: active tDCS plus placebo CT
    Participants will receive active transcranial direct current stimulation and placebo cognitive training.
    Interventions:
    • Device: active tDCS
    • Behavioral: placebo CT
  • Placebo Comparator: sham tDCS plus placebo CT
    Participants will receive sham transcranial direct current stimulation and placebo cognitive training.
    Interventions:
    • Device: sham tDCS
    • Behavioral: placebo CT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 11, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2019
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02772185
Other Study ID Numbers  ICMJE NeuroAD
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Suellen Marinho Andrade, Federal University of Paraíba
Study Sponsor  ICMJE Federal University of Paraíba
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Federal University of Paraíba
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP