Premium
O3–05–05: Therapeutic effects of daily intranasal insulin administration in early Alzheimer's disease
Author(s) -
Craft Suzanne,
Reger Mark,
Baker Laura D.,
Watson G. Stennis,
Fishel Mark,
Cholerton Brenna,
Green Pattie,
Breitner John C.S.,
DeGroodt William,
Frey William H.
Publication year - 2006
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.2006.05.227
Subject(s) - insulin , hypoglycemia , medicine , nasal administration , placebo , adverse effect , endocrinology , pharmacology , alternative medicine , pathology
human antibody product that contains natural antibodies against the amyloid beta peptide (A ). Eight patients with mild to moderate stage Alzheimer’s disease (AD) were treated with IVIg in an open label dose-finding Phase Ia clinical study. Subjects treated for 6 months with doses of IVIg between 0.4g/kg/2 weeks and 2g/kg/month remained stable or improved an average of 2.75 points on the Folstein MMSE (mean 26, range 20-29). All subjects had significantly lower cerebrospinal fluid A levels after six months of treatment relative to baseline. Subsequent washout of IVIg for 3 months led to a return to the pre-treatment cognitive state. Objective(s): To determine whether resumption of IVIg treatment after washout exerts beneficial effects on cognition in AD patients. Methods: All eight patients (1M, 7F) who completed the Phase Ia IVIg treatment trial gave informed consent for resumption of IVIg infusions for an additional nine months. In Phase Ib, subjects with a mean age of 75 (range 67-86) were treated with IVIg (Gammagard S/D) at a dose of 1g/kg/2 weeks for 3 months followed by 0.4g/kg/2 weeks for 6 months. Subjects were maintained on stable doses of cholinesterase inhibitors and memantine during this extension study. Mental status was assessed using MMSE immediately post-washout and every three months following subsequent commencement of IVIg treatment. Results: In contrast to the rapid decline subjects experienced during washout, cognitive status remained stable throughout the first three months of follow-up treatment and trended upward in the majority of cases during the remaining 6 months. MMSE scores in all our patients who have completed Phase Ib to date are stable or have increased relative to their baseline MMSE scores at entry into Phase Ia. Only minor treatment-related side effects occurred during this nine-month extension study. Conclusions: Resumption of IVIg treatment after a washout period led to extension of cognitive benefits for a period encompassing 18 months from the time of initial treatment. This study suggests that IVIg can exert long-term benefits for the treatment of cognitive decline in Alzheimer’s disease. Support: WMC GCRC M01 RR00047, Grant from Baxter BioScience.