Clinical trial NCT02772185: Neurostimulation and Cognitive Intervention in Alzheimer's Disease
Official title: Neurostimulation and Cognitive Intervention in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Alzheimer's Disease
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in cognitive function assessed on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)
timeFrame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Secondary outcomes:
measure: Change in cognitive ability assessed on the Wechsler Adult Intelligence Scale
timeFrame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
measure: Change in visuo-spatial working memory assessed on the Corsi block task
timeFrame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
measure: Change in verbal working memory assessed on the Digit Span task
timeFrame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
measure: Change in speed of cognitive processing and executive functioning assessed on the Trail Making Test
timeFrame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
measure: Change in executive function assessed on the Stroop Color and Word Test
timeFrame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
measure: Change in verbal fluency assessed on the FAS Verbal Fluency Test
timeFrame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
measure: Change in functional ability assessed on the Disability Assessment Dementia
timeFrame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
measure: Change in visual recognition assessed on the Poppelreuter-Ghent's Overlapping Figures test
timeFrame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
measure: Change in behavioral and psychological disturbances assessed on the Neuropsychiatric Inventory Questionnaire
timeFrame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
measure: Change in subjective burden among caregivers assessed on the Zarit Burden Interview
timeFrame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
measure: Change in electrical activity of the brain assessed on the Electroencephalogram (EEG)
timeFrame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
measure: Side Effects Questionnaire
timeFrame: From date of first neurostimulation until the date of last neurostimulation, assessed up to 12 months
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Suellen Andrade
state: PB
Study officials:
References:
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.
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.