Neurostimulation and Cognitive Intervention in Alzheimer's Disease

Federal University of Paraíba1 site in 1 country60 target enrollmentMay 2016

ConditionsAlzheimer's Disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Alzheimer's Disease
Sponsor: Federal University of Paraíba
Enrollment: 60
Locations: 1
Primary Endpoint: Change in cognitive function assessed on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2016

End Date

May 2019

Last Updated

9 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Federal University of Paraíba

Responsible Party

Principal Investigator

Suellen Marinho Andrade

Professor

Federal University of Paraíba

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

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 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 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 visuo-spatial working memory assessed on the Corsi block task(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 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 subjective burden among caregivers assessed on the Zarit Burden Interview(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)
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 electrical activity of the brain assessed on the Electroencephalogram (EEG)(Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months))