Clinical correlates and baseline predictors of progressive brain atrophy in progressive supranuclear palsy: results from the AL-108-231 davunetide trial (P5.006)
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).…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 313 participants or records.
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