Neurostimulation and Cognitive Intervention in Alzheimer's Disease

Phase 2

• Conditions: Alzheimer's Disease
• Interventions: Device: active tDCS; Device: sham tDCS; Behavioral: placebo CT; Behavioral: real CT

• Registration Number: NCT02772185
• Lead Sponsor: Federal University of Paraíba

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 Timeline

• Status Verified: 2016-05
• Study Start: 2016-05
• Study First Submitted: 2016-05-05
• Study First Submitted QC: 2016-05-11
• Last Update Submitted: 2016-05-11
• Study First Posted: 2016-05-13
• Last Update Posted: 2016-05-13
• Primary Completion: 2018-05
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
active tDCS plus placebo CT	placebo CT	Participants will receive active transcranial direct current stimulation and placebo cognitive training.
active tDCS plus placebo CT	active tDCS	Participants will receive active transcranial direct current stimulation and placebo cognitive training.
active tDCS plus real CT	real CT	Participants will receive active transcranial direct current stimulation and real cognitive training.
sham tDCS plus placebo CT	sham tDCS	Participants will receive sham transcranial direct current stimulation and placebo cognitive training.
active tDCS plus real CT	active tDCS	Participants will receive active transcranial direct current stimulation and real cognitive training.
sham tDCS plus real CT	real CT	Participants will receive sham transcranial direct current stimulation and real cognitive training.
sham tDCS plus real CT	sham tDCS	Participants will receive sham transcranial direct current stimulation and real cognitive training.
sham tDCS plus placebo CT	placebo CT	Participants will receive sham transcranial direct current stimulation and placebo cognitive training.

Primary Outcome Measures

Name	Time	Method
Change in cognitive function assessed on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)	Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Suellen Andrade; 🇧🇷 João Pessoa, PB, Brazil