Neurostimulation and Cognitive Intervention in Alzheimer's Disease

Neurostimulation and Cognitive Intervention in Alzheimer's Disease

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.

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.

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