Premium
O4‐09‐02: Quantitative Eeg Can Identify Difference Between Patients with Alzheimer's Disease and Healthy Volunteers on an Individual Level
Author(s) -
Blackburn Daniel J.,
Zhou Yifan,
Bell Simon,
De Marco Matteo,
Wilkinson Iain,
He Fei,
Wei Hua Liang,
Farrow Thomas,
Venneri Annalena,
Sarrigiannis Ptolemaios
Publication year - 2016
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.2016.06.655
Subject(s) - electroencephalography , neuropsychology , audiology , psychology , significant difference , set (abstract data type) , resting state fmri , medicine , neuroscience , cognition , computer science , programming language
ate AD patients were administered a single IV dose of LY (0.1 mg/kg IV to 10 mg/kg IV) or placebo during the single ascending dose (SAD) phase, followed by a 12 week follow-up period. The same patients proceeded into the multiple-ascending dose (MAD) phase and were administered up to 4 additional monthly IV doses of LY (0.3 mg/kg IV to 10 mg/kg IV) or placebo, depending on the initial SAD cohort. Adverse events, vital signs, ECGs, clinical laboratories, and neurological exams were assessed throughout the study and for up to 84 days after last dose to characterize safety and tolerability. Results: 37 patients received LY and 12 received placebo in the SAD/MAD cohorts. The 49 subjects had a mean age of 74 yrs (68yrs) with 57% female and 43%male. 53% had a Clinical Dementia Rating (CDR)1⁄40.5; 43% had CDR1⁄41, and 4% had CDR1⁄42. Subjects had florbetapir PET scans at screening and 7 months after the first dose (233644 days from screening) for quantitation of change in cerebral amyloid burden. MRI assessments for amyloid related imaging abnormalities were performed at screening, four weeks after the single dose, and at the end of the multiple dose phase. PK and immunogenicity assessments were performed throughout the trial. Conclusions: Safety, pharmacokinetics (PK), and florbetapir PET after multiple dose administration of LY will be presented.