Neurostimulation and Cognitive Intervention in Alzheimer's Disease

Alzheimer's Disease Clinical Trial

— NeuroAD  

Official title:

Neurostimulation and Cognitive Intervention in Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02772185
• Other study ID #: NeuroAD
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: May 5, 2016
• Last updated: May 11, 2016
• Start date: May 2016
• Est. completion date: May 2019

Study information

• Verified date: May 2016
• Source: Federal University of Paraíba
• Contact: Suellen M Andrade, PhD
• Email: suellenandrade[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2019
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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
• 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).
• placebo CT
Videos (short films) will be presented during the neurostimulation

Locations

Country	Name	City	State
Brazil	Suellen Andrade	João Pessoa	PB

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Change in functional ability assessed on the Disability Assessment Dementia		Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Side Effects Questionnaire		From date of first neurostimulation until the date of last neurostimulation, assessed up to 12 months	Yes