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Rapid eye movement sleep behavior disorder: A proof-of-concept neuroprotection study for prodromal synucleinopathies.
Arnaldi, Dario; Famà, Francesco; Girtler, Nicola; Brugnolo, Andrea; Pardini, Matteo; Mattioli, Pietro; Meli, Riccardo; Massa, Federico; Orso, Beatrice; Sormani, Maria Pia; Donegani, Maria Isabella; Bauckneht, Matteo; Morbelli, Silvia; Nobili, Flavio.
Afiliação
  • Arnaldi D; Clinical Neurology, Department of Neuroscience (DINOGMI, University of Genoa, Genoa, Italy.
  • Famà F; IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
  • Girtler N; Clinical Neurology, Department of Neuroscience (DINOGMI, University of Genoa, Genoa, Italy.
  • Brugnolo A; IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
  • Pardini M; Clinical Neurology, Department of Neuroscience (DINOGMI, University of Genoa, Genoa, Italy.
  • Mattioli P; IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
  • Meli R; Clinical Neurology, Department of Neuroscience (DINOGMI, University of Genoa, Genoa, Italy.
  • Massa F; IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
  • Orso B; Clinical Neurology, Department of Neuroscience (DINOGMI, University of Genoa, Genoa, Italy.
  • Sormani MP; IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
  • Donegani MI; Clinical Neurology, Department of Neuroscience (DINOGMI, University of Genoa, Genoa, Italy.
  • Bauckneht M; IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
  • Morbelli S; Clinical Neurology, Department of Neuroscience (DINOGMI, University of Genoa, Genoa, Italy.
  • Nobili F; IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
Eur J Neurol ; 28(4): 1210-1217, 2021 04.
Article em En | MEDLINE | ID: mdl-33275819
BACKGROUND AND PURPOSE: To explore the feasibility of a neuroprotection trial in prodromal synucleinopathy, using idiopathic rapid eye movement sleep behavior disorder (iRBD) as the target population and 123 I-FP-CIT-SPECT as a biomarker of disease progression. METHODS: Consecutive iRBD patients were randomly assigned to a treatment arm receiving selegiline and symptomatic rapid eye movement sleep behavior disorder treatment, or to a control arm receiving symptomatic treatment only. Selegiline was chosen because of a demonstrated neuroprotection effect in animal models. Patients underwent 123 I-FP-CIT-SPECT at baseline and after 30 months on average. The clinical outcome was the emergence of parkinsonism and/or dementia. A repeated-measures general linear model (GLM) was applied using group (control and treatment) as "between" factor, and both time (baseline and follow-up) and regions (123 I-FP-CIT-SPECT putamen and caudate uptake) as the "within" factors, adjusting for age. RESULTS: Thirty iRBD patients completed the study (68.2 ± 6.9 years; 29 males; 21% dropout rate), 13 in the treatment arm, and 17 in the control arm. At follow-up (29.8 ± 9.0 months), three patients in the control arm developed dementia and one parkinsonism, whereas two patients in the treatment arm developed parkinsonism. Both putamen and caudate uptake decreased over time in the control arm. In the treatment arm, only the putamen uptake decreased over time, whereas caudate uptake remained stable. GLM analysis demonstrated an effect of treatment on the 123 I-FP-CIT-SPECT uptake change, with a significant interaction between the effect of group, time, and regions (p = 0.004). CONCLUSIONS: A 30-months neuroprotection study for prodromal synucleinopathy is feasible, using iRBD as the target population and 123 I-FP-CIT-SPECT as a biomarker of disease progression.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Transtorno do Comportamento do Sono REM / Sinucleinopatias Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2021 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Transtorno do Comportamento do Sono REM / Sinucleinopatias Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2021 Tipo de documento: Article