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Neurostimulation and Cognitive Intervention in Alzheimer's Disease

NCT02772185 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-05-13

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Federal University of Paraíba

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-05-31
Completion
2019-05-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02772185 on ClinicalTrials.gov