Title | Safety and Tolerability of R(+) Pramipexole in Mild-to-Moderate Alzheimer's Disease. |
Publication Type | Journal Article |
Year of Publication | 2016 |
Authors | Bennett, J, Burns, J, Welch, P, Bothwell, R |
Journal | J Alzheimers Dis |
Volume | 49 |
Issue | 4 |
Pagination | 1179-87 |
Date Published | 2016 |
ISSN | 1875-8908 |
Keywords | Aged, Alzheimer Disease, Amyloid beta-Peptides, Benzothiazoles, Biomarkers, Brain, Female, Glucose, Humans, Male, Neuropsychological Tests, Nootropic Agents, Peptide Fragments, Positron-Emission Tomography, Severity of Illness Index, tau Proteins, Treatment Outcome |
Abstract | Alzheimer's disease (AD) is an aging-related, degenerative brain disease of adults. Most (∼95%) of AD occurs sporadically and is associated with early-appearing deficits in brain regional glucose uptake, changes in cerebrospinal fluid (CSF) AD-related proteins, regional brain atrophy, and oxidative stress damage. We treated mild-moderate AD individuals with R(+)-pramipexole-dihydrochloride (R(+)PPX), a neuroprotective, lipophilic-cation, free-radical scavenger that accumulates into brain and mitochondria. 19 subjects took R(+)PPX twice a day in increasing daily doses up to 300 mg/day under a physician-sponsor IND (60,948, JPB), IRB-approved protocol and quarterly external safety committee monitoring. 15 persons finished and contributed baseline and post-treatment serum, lumbar spinal fluid, brain 18F-2DG PET scans, and ADAS-Cog scores. ADAS-Cog scores did not change (n = 1), improved (n = 2), declined 1-3 points (n = 5), or declined 4-13 points (n = 8) over 6 months of R(+)PPX treatment. Serum PPX levels were not related to changes in ADAS-Cog scores. Fasting AM serum PPX levels at 6 months varied considerably across subjects and correlated strongly with CSF [PPX] (r = 0.97, p |
DOI | 10.3233/JAD-150788 |
Alternate Journal | J. Alzheimers Dis. |
PubMed ID | 26682692 |