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

Primary Purpose

Alzheimer's Disease

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
active tDCS
sham tDCS
real CT
placebo CT
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Suellen AndradeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

active tDCS plus real CT

sham tDCS plus real CT

active tDCS plus placebo CT

sham tDCS plus placebo CT

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Change in cognitive function assessed on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)

Secondary Outcome Measures

Change in cognitive ability assessed on the Wechsler Adult Intelligence Scale
Change in visuo-spatial working memory assessed on the Corsi block task
Change in verbal working memory assessed on the Digit Span task
Change in speed of cognitive processing and executive functioning assessed on the Trail Making Test
Change in executive function assessed on the Stroop Color and Word Test
Change in verbal fluency assessed on the FAS Verbal Fluency Test
Change in functional ability assessed on the Disability Assessment Dementia
Change in visual recognition assessed on the Poppelreuter-Ghent's Overlapping Figures test
Change in behavioral and psychological disturbances assessed on the Neuropsychiatric Inventory Questionnaire
Change in subjective burden among caregivers assessed on the Zarit Burden Interview
Change in electrical activity of the brain assessed on the Electroencephalogram (EEG)
Side Effects Questionnaire

Full Information

First Posted
May 5, 2016
Last Updated
May 11, 2016
Sponsor
Federal University of Paraíba
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1. Study Identification

Unique Protocol Identification Number
NCT02772185
Brief Title
Neurostimulation and Cognitive Intervention in Alzheimer's Disease
Acronym
NeuroAD
Official Title
Neurostimulation and Cognitive Intervention in Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active tDCS plus real CT
Arm Type
Experimental
Arm Description
Participants will receive active transcranial direct current stimulation and real cognitive training.
Arm Title
sham tDCS plus real CT
Arm Type
Experimental
Arm Description
Participants will receive sham transcranial direct current stimulation and real cognitive training.
Arm Title
active tDCS plus placebo CT
Arm Type
Experimental
Arm Description
Participants will receive active transcranial direct current stimulation and placebo cognitive training.
Arm Title
sham tDCS plus placebo CT
Arm Type
Placebo Comparator
Arm Description
Participants will receive sham transcranial direct current stimulation and placebo cognitive training.
Intervention Type
Device
Intervention Name(s)
active tDCS
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
The procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham.
Intervention Type
Behavioral
Intervention Name(s)
real CT
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
placebo CT
Intervention Description
Videos (short films) will be presented during the neurostimulation
Primary Outcome Measure Information:
Title
Change in cognitive function assessed on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)
Time Frame
Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Secondary Outcome Measure Information:
Title
Change in cognitive ability assessed on the Wechsler Adult Intelligence Scale
Time Frame
Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Title
Change in visuo-spatial working memory assessed on the Corsi block task
Time Frame
Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Title
Change in verbal working memory assessed on the Digit Span task
Time Frame
Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Title
Change in speed of cognitive processing and executive functioning assessed on the Trail Making Test
Time Frame
Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Title
Change in executive function assessed on the Stroop Color and Word Test
Time Frame
Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Title
Change in verbal fluency assessed on the FAS Verbal Fluency Test
Time Frame
Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Title
Change in functional ability assessed on the Disability Assessment Dementia
Time Frame
Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Title
Change in visual recognition assessed on the Poppelreuter-Ghent's Overlapping Figures test
Time Frame
Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Title
Change in behavioral and psychological disturbances assessed on the Neuropsychiatric Inventory Questionnaire
Time Frame
Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Title
Change in subjective burden among caregivers assessed on the Zarit Burden Interview
Time Frame
Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Title
Change in electrical activity of the brain assessed on the Electroencephalogram (EEG)
Time Frame
Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Title
Side Effects Questionnaire
Time Frame
From date of first neurostimulation until the date of last neurostimulation, assessed up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suellen M Andrade, PhD
Email
suellenandrade@gmail.com
Facility Information:
Facility Name
Suellen Andrade
City
João Pessoa
State/Province
PB
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suellen Andrade
Email
suellenandrade@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
33883015
Citation
Marchi LZ, Ferreira RGD, de Lima GNS, da Silva JAS, da Cruz DMC, Fernandez-Calvo B, Andrade SMMDS. Multisite transcranial direct current stimulation associated with cognitive training in episodic memory and executive functions in individuals with Alzheimer's disease: a case report. J Med Case Rep. 2021 Apr 22;15(1):185. doi: 10.1186/s13256-021-02800-x.
Results Reference
derived
PubMed Identifier
30450044
Citation
Andrade SM, de Oliveira EA, Alves NT, Dos Santos ACG, de Mendonca CTPL, Sampaio DDA, da Silva EEQC, da Fonseca EKG, de Almeida Rodrigues ET, de Lima GNS, Carvalho J, da Silva JAS, Toledo M, da Rosa MRD, Gomes MQC, de Oliveira MM, Lemos MTM, Lima NG, Inacio P, da Cruz Ribeiro E Rodrigues PM, Ferreira RGD, Cavalcante R, de Brito Aranha REL, Neves R, da Costa E Souza RM, Portugal TM, Martins WKN, Pontes V, de Paiva Fernandes TM, Contador I, Fernandez-Calvo B. Neurostimulation Combined With Cognitive Intervention in Alzheimer's Disease (NeuroAD): Study Protocol of Double-Blind, Randomized, Factorial Clinical Trial. Front Aging Neurosci. 2018 Nov 2;10:334. doi: 10.3389/fnagi.2018.00334. eCollection 2018.
Results Reference
derived

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Neurostimulation and Cognitive Intervention in Alzheimer's Disease

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