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

F

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

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

Trial contacts and locations

1

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Central trial contact

Suellen M Andrade, PhD

Data sourced from clinicaltrials.gov

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