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

May 11, 2016 updated by: Suellen Marinho Andrade, Federal University of Paraíba
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.
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).
Device: sham tDCS
The procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
From date of first neurostimulation until the date of last neurostimulation, assessed up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Paraíba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

May 5, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (Estimate)

May 13, 2016

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NeuroAD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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