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

• ClinicalTrials.gov Identifier: NCT02772185
• Recruitment Status: Unknown
• First Posted: May 13, 2016
• Last Update Posted: May 13, 2016
• Sponsor: Federal University of Paraíba
• Information provided by (Responsible Party): Suellen Marinho Andrade, Federal University of Paraíba

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.

Condition or disease	Intervention/treatment	Phase
Alzheimer's Disease	Device: active tDCS; Device: sham tDCS; Behavioral: real CT; Behavioral: placebo CT	Phase 2; Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Neurostimulation and Cognitive Intervention in Alzheimer's Disease
• Study Start Date: May 2016
• Estimated Primary Completion Date: May 2018
• Estimated Study Completion Date: May 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: active tDCS plus real CT; Participants will receive active transcranial direct current stimulation and real cognitive training.	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; 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).
Experimental: sham tDCS plus real CT; Participants will receive sham transcranial direct current stimulation and real cognitive training.	Device: 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).
Experimental: active tDCS plus placebo CT; Participants will receive active transcranial direct current stimulation and placebo cognitive training.	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; Behavioral: placebo CT; Videos (short films) will be presented during the neurostimulation
Placebo Comparator: sham tDCS plus placebo CT; Participants will receive sham transcranial direct current stimulation and placebo cognitive training.	Device: sham tDCS; The procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham.; Behavioral: placebo CT; Videos (short films) will be presented during the neurostimulation

Outcome Measures

Primary Outcome Measures :

1. 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 Measures :

1. 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) ]
2. 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) ]
3. 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) ]
4. 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) ]
5. 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) ]
6. 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) ]
7. 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) ]
8. 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) ]
9. 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) ]
10. 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) ]
11. 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) ]
12. Side Effects Questionnaire [ Time Frame: From date of first neurostimulation until the date of last neurostimulation, assessed up to 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Suellen M Andrade, PhD; suellenandrade@gmail.com

Locations

Brazil

Suellen Andrade; Recruiting

João Pessoa, PB, Brazil

Contact: Suellen Andrade

Contact suellenandrade@gmail.com

Sponsors and Collaborators

Federal University of Paraíba

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Andrade SM, de Oliveira EA, Alves NT, Dos Santos ACG, de Mendonça CTPL, Sampaio DDA, da Silva EEQC, da Fonsêca ÉKG, 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, Inácio 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, Fernández-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.

• Responsible Party: Suellen Marinho Andrade, Professor, Federal University of Paraíba
• ClinicalTrials.gov Identifier: NCT02772185
• Other Study ID Numbers: NeuroAD
• First Posted: May 13, 2016
• Last Update Posted: May 13, 2016
• Last Verified: May 2016

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders