Neurostimulation and Cognitive Intervention in Alzheimer's Disease

NCT ID: NCT02772185

Last Updated: 2016-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-05-31

Brief Summary

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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

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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.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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active tDCS plus real CT

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

Group Type EXPERIMENTAL

active tDCS

Intervention Type DEVICE

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

real CT

Intervention Type BEHAVIORAL

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).

sham tDCS plus real CT

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

Group Type EXPERIMENTAL

sham tDCS

Intervention Type DEVICE

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

real CT

Intervention Type BEHAVIORAL

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 placebo CT

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

Group Type EXPERIMENTAL

active tDCS

Intervention Type DEVICE

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

placebo CT

Intervention Type BEHAVIORAL

Videos (short films) will be presented during the neurostimulation

sham tDCS plus placebo CT

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

Group Type PLACEBO_COMPARATOR

sham tDCS

Intervention Type DEVICE

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

placebo CT

Intervention Type BEHAVIORAL

Videos (short films) will be presented during the neurostimulation

Interventions

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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

Intervention Type DEVICE

sham tDCS

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

Intervention Type DEVICE

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).

Intervention Type BEHAVIORAL

placebo CT

Videos (short films) will be presented during the neurostimulation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Paraíba

OTHER

Sponsor Role lead

Responsible Party

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Suellen Marinho Andrade

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Suellen Andrade

João Pessoa, Paraíba, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Suellen M Andrade, PhD

Role: CONTACT

Facility Contacts

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Suellen Andrade

Role: primary

Role: backup

References

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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.

Reference Type DERIVED
PMID: 37859768 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33883015 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30450044 (View on PubMed)

Other Identifiers

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NeuroAD

Identifier Type: -

Identifier Source: org_study_id

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