NCT02772185

Neurostimulation and Cognitive Intervention in Alzheimer's Disease

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Federal University of Paraíba · Academic / Other
• Sex: All
• Age: 60 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-05-01
• Completion: 2019-05-01
• First posted: 2016-05-13
• Last updated: 2016-05-13

Locations

1 site across 1 country: Brazil