NCT02772185

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

2 years

First QC Date

May 5, 2016

Last Update Submit

May 11, 2016

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (12)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • +7 more secondary outcomes

Study Arms (4)

active tDCS plus real CT

EXPERIMENTAL

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

Device: active tDCSBehavioral: real CT

sham tDCS plus real CT

EXPERIMENTAL

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

Device: sham tDCSBehavioral: real CT

active tDCS plus placebo CT

EXPERIMENTAL

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

Device: active tDCSBehavioral: placebo CT

sham tDCS plus placebo CT

PLACEBO COMPARATOR

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

Device: sham tDCSBehavioral: placebo CT

Interventions

active tDCSDEVICE

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

active tDCS plus placebo CTactive tDCS plus real CT
sham tDCSDEVICE

The procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham.

sham tDCS plus placebo CTsham tDCS plus real CT
real CTBEHAVIORAL

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).

active tDCS plus real CTsham tDCS plus real CT
placebo CTBEHAVIORAL

Videos (short films) will be presented during the neurostimulation

active tDCS plus placebo CTsham tDCS plus placebo CT

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suellen Andrade

João Pessoa, Paraíba, Brazil

RECRUITING

Related Publications (3)

  • Andrade SM, da Silva-Sauer L, de Carvalho CD, de Araujo ELM, Lima EO, Fernandes FML, Moreira KLAF, Camilo ME, Andrade LMMDS, Borges DT, da Silva Filho EM, Lindquist AR, Pegado R, Morya E, Yamauti SY, Alves NT, Fernandez-Calvo B, de Souza Neto JMR. Identifying biomarkers for tDCS treatment response in Alzheimer's disease patients: a machine learning approach using resting-state EEG classification. Front Hum Neurosci. 2023 Oct 4;17:1234168. doi: 10.3389/fnhum.2023.1234168. eCollection 2023.

    PMID: 37859768DERIVED

  • 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.

    PMID: 33883015DERIVED

  • 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.

    PMID: 30450044DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Suellen M Andrade, PhD

CONTACT

suellenandrade@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 5, 2016

First Posted

May 13, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2019

Last Updated

May 13, 2016

Record last verified: 2016-05

Locations

BR(1)