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

Federal University of Paraíba

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Alzheimer's Disease

Treatments: Behavioral: placebo CT; Device: active tDCS; Behavioral: real CT; Device: sham tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT02772185

NeuroAD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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60 participants in 4 patient groups, including a placebo group

active tDCS plus real CT

Experimental group

Description:

Participants will receive active transcranial direct current stimulation and real cognitive training.

Treatment:

Behavioral: real CT

Device: active tDCS

sham tDCS plus real CT

Experimental group

Description:

Participants will receive sham transcranial direct current stimulation and real cognitive training.

Treatment:

Behavioral: real CT

Device: sham tDCS

active tDCS plus placebo CT

Experimental group

Description:

Participants will receive active transcranial direct current stimulation and placebo cognitive training.

Treatment:

Behavioral: placebo CT

Device: active tDCS

sham tDCS plus placebo CT

Placebo Comparator group

Description:

Participants will receive sham transcranial direct current stimulation and placebo cognitive training.

Treatment:

Device: sham tDCS

Behavioral: placebo CT