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P2‐030: INTENSIVE LANGUAGE TRAINING COMBINED WITH TRANSCRANIAL STIMULATION IN PATIENTS WITH LOGOPENIC APHASIA
Author(s) -
Ferrari Jesica,
Borovinsky Geraldine,
Alejandra Suarez Diana María,
Birba Agustina,
Pontello Noelia,
Manes Facundo,
Martínez-Cuitiño Macarena,
Zimerman Máximo
Publication year - 2018
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2018.06.714
Subject(s) - transcranial direct current stimulation , aphasia , audiology , noun , brain stimulation , primary progressive aphasia , psychology , stimulation , language production , medicine , cognitive psychology , neuroscience , computer science , cognition , artificial intelligence , dementia , disease , frontotemporal dementia
evaluable subjects. During dosing periods subjects will reside in inpatient observation units to facilitate safety evaluation. Subjects will undergo a screening visit, baseline visit, treatment visits, follow-up visits, and an end of study/early termination visit. Safety and tolerability assessments will occur at every visit. Neurocognitive and motor assessments will be performed at baseline and at periodic interim visits following dosing. Results: The primary endpoints are safety, tolerability, and feasibility of the dosing regimen. Safety will be measured by the incidence of treatmentemergent adverse events. Tolerability will be measured by the number of subjects completing the week-8 follow-up visit and subjects completing the week-24 follow-up visit. Study feasibility will be measured by the number of subjects completing each infusion regimen. Secondary endpoints will assess potential effects on cognition using various established cognitive measures including the Alzheimer’s Disease Assessment Scale-Cognitive Subscale. Exploratory endpoints include assessment of changes in composition and distribution of blood-based biomarkers and MR imaging. Conclusions: Robust preclinical evidence in rodents provides the foundation to test the translatability of these findings in humans. In this Phase 2 study, the safety, tolerability, and feasibility of multiple infusions of GRF6019 in subjects with AD will be assessed. Continued clinical development in AD will be informed by safety and efficacy data emerging from this trial.