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Galantamine treatment in outpatients with mild Alzheimer’s disease

Authors

Richarz, U., Gaudig, M., Rettig, K., Schäuble, B.

Journal

Acta Neurologica Scandinavica, Volume: 129, No.: 6, Pages.: 382-392

Year of Publication

2014

Abstract

Objective: To assess long-term effectiveness of galantamine in community-dwelling persons with mild Alzheimer’s disease.; Methods: Prospective open-label trial including patients with mild AD (NINCDS-ADRDA criteria) treated with galantamine for up to 36 months. Outcome parameters included ADAS-cog/11, Bayer-ADL scale (self- and caregivers’ ratings), 10-item NPI and CGI-change, safety and tolerability measures. Data are presented based on ITT analyses (LOCF).; Results: Seventy-five patients (55% women; mean ADAS-cog 22.3; mean age 70.2 years) were treated with galantamine for approximately 36 months. About 60% (n=45) received a total daily dose of 24 mg galantamine at final visit. After 3, 6, and 12 months of treatment, mean improvements in ADAS-cog ranged between 2.2 and 3.0 points (all P<0.05). After 24-month treatment, ADAS-cog returned to baseline value and at 3-year follow-up, patient deteriorated on average by 2.9 points. There was significant improvement on the NPI scale between baseline and 3- to 12-month follow-up (all P<0.05) and at 3-year endpoint, a slight deterioration was noted. Activities of daily living (B-ADL) decreased significantly after 24 months in self-ratings and after 12 months in caregivers' ratings. Fifty-four patients reported at least one AE, most of them occurring during the first 2 years of treatment. Among the most frequently (>10%) reported AEs irrespective of causal relationship to study medication were nausea (17.3%), dizziness (12%), and vomiting (10.7%).; Conclusion: Galantamine was generally safe and well tolerated during the 3-year observation period. Cognition, behavior, and activities of daily living improved during 12 months treatment. At 3-year follow-up, worsening in all outcomes was measured; however, cognition remained improved compared with an untreated population.; © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Bibtex Citation

@article{Richarz_2014, doi = {10.1111/ane.12195}, url = {http://dx.doi.org/10.1111/ane.12195}, year = 2014, month = {jan}, publisher = {Wiley-Blackwell}, volume = {129}, number = {6}, pages = {382--392}, author = {U. Richarz and M. Gaudig and K. Rettig and B. Schauble}, title = {Galantamine treatment in outpatients with mild Alzheimer{textquotesingle}s disease}, journal = {Acta Neurologica Scandinavica} }

Keywords

activities of daily living, adascog, adverse, adverse effects, aged, alzheimer disease, alzheimer’s disease, bayer activity of daily living scale, cognition, drug effects, drug therapy, events, female, galantamine, humans, male, neuropsychiatric inventory, nootropic agents, outpatients, prospective studies, severity of illness index, therapeutic use, time factors, treatment outcome

Countries of Study

USA

Types of Dementia

Alzheimer’s Disease

Types of Study

Cohort Study

Type of Outcomes

ADLs/IADLs, Behaviour, Cognition, Other

Settings

Community

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

Anti-Alzheimer medications, e.g.: donezepil, galantamine, rivastigmine, memantime