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- W858486404 abstract "Objective: To determine if volumetric MRI (vMRI) brain changes can serve as a biomarker for progressive supranuclear palsy disease (PSP) progression, and whether baseline clinical traits predict brain atrophy rates.Background: The AL-108-231 study was a phase 2/3 double-blind, placebo-controlled trial for PSP. It was conducted at 48 centers on three continents and randomized 313 patients to davunetide (neurotrophic peptide) or placebo for one year with serial MRI scans and clinical data. This study evaluated the clinical correlates of vMRI changes in PSP.Design/Methods: Patients with baseline and week 52 MRI scans, Progressive Supranuclear Palsy Rating Scale (PSPRS) (n=192), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (n=190) and color trails 1, 2 (n = 190, 183) test scores were included for analysis. Brain volumes derived by label propagation in SPM5. Linear regression was used to investigate the relationship between baseline, changes in PSPRS, RBANS, color trails scores and whole brain, ventricular, midbrain and superior cerebellar peduncle (SCP) volume changes. Age, sex, disease duration, H1 haplotype, CoQ10 status, treatment group and total intracranial volume were used as covariates.Results: Change in PSPRS, RBANS and color trails were correlated with brain volume changes (p<0.01). Baseline RBANS memory, language, total scores and color trails scores significantly predicted whole brain, midbrain volume changes respectively (p<0.01). Baseline PSPRS did not predict brain volume changes. The rate of whole brain, midbrain and ventricular volume changes per annum were similar to and confirm previous findingsConclusions: Our data suggest PSP brain volume changes on vMRI capture disease progression and cognitive changes. vMRI changes may serve as a valuable biomarker or outcome to support disease modifying therapeutic efficacy in future PSP clinical trials. Baseline neuropsychological testing may be useful for patient selection for more efficient future clinical trials.Study supported by: Tau Consortium, Allon Pharmaceuticals, NIH Disclosure: Dr. Tsai has nothing to disclose. Dr. Lobach has nothing to disclose. Dr. Whitwell has nothing to disclose. Dr. Senjem has nothing to disclose. Dr. Jack has received personal compensation for activities with Janssen Pharmaceuticals as a consultant. Dr. Jack has received research support from the National Institutes of Health. Dr. Boxer has received personal compensation for activities with Archer Pharmaceuticals, EnVivo Pharmaceuticals, Grifols, and iPerian as a consultant." @default.
- W858486404 created "2016-06-24" @default.
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- W858486404 date "2015-04-06" @default.
- W858486404 modified "2023-09-23" @default.
- W858486404 title "Clinical correlates and baseline predictors of progressive brain atrophy in progressive supranuclear palsy: results from the AL-108-231 davunetide trial (P5.006)" @default.
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