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An open-label extension trial of galantamine in patients with probable vascular dementia and mixed dementia.
Clin Ther. 2003 Jun; 25(6):1765-82.CT

Abstract

BACKGROUND

Alzheimer's disease (AD) and vascular dementia (VaD) are the most common types of dementia worldwide. Galantamine, an acetylcholinesterase inhibitor and allosteric nicotinic modulator, has shown broad clinical benefits in patients with mild to moderate dementia due to AD, probable VaD, or AD with cerebrovascular disease (CVD)-so-called mixed dementia.

OBJECTIVE

The purpose of this study was to evaluate the efficacy and safety profiles of galantamine 24 mg/d in patients with VaD or AD with CVD over the longer term (>6 months).

METHODS

This was an open-label extension of a 6-month double-blind study of galantamine. Patients who had been randomized to receive galantamine 24 mg/d or placebo in the double-blind phase were eligible to continue open-label treatment with galantamine 24 mg/d for 6 months. The primary efficacy end point was change in cognition, based on scores on the 11-item Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog/11). Secondary measures included changes in functional ability (as measured on the Disability Assessment for Dementia [DAD]) and behavior (as measured on the Neuropsychiatric Inventory [NPI]). Safety and tolerability were also monitored.

RESULTS

Four hundred fifty-nine patients (240 men, 219 women; mean [SE] age, 75.2 [0.33] years) entered the open-label phase. Of these patients, 195 (42.5%) had a diagnosis of probable VaD, and 238 (51.9%) had a diagnosis of AD with CVD; the remainder had an inconclusive diagnosis. At month 12 of the study, improvements from baseline (the start of the double-blind phase) in ADAS-cog/11 scores were observed in both the group that received placebo during the double-blind phase (placebo/galantamine group: -0.3 point; 95% CI, -1.64 to 1.06) and the group that received galantamine during the double-blind phase (galantamine/galantamine group: -0.9 point; 95% CI, -1.73 to 0.03). Improvement in functional ability was demonstrated by statistically significant mean (SE) changes from baseline in DAD score in both the placebo/galantamine group (-7.4 [1.68]; P < or = 0.001) and the galantamine/galantamine group (-3.6 [1.33]; P < or = 0.01). There was no significant change in mean (SE) NPI scores in either group (0.2 [0.98] and 0.1 [0.70], respectively). Galantamine treatment was well tolerated.

CONCLUSIONS

In these patients with VaD and AD with CVD, galantamine treatment produced similar sustained benefits in terms of maintenance of or improvement in cognition (ADAS-cog/11), functional ability (DAD), and behavior (NPI) after 12 months.

Authors+Show Affiliations

Erkinjuntti T
Department of Clinical Neurosciences, Helsinki University Central Hospital, Helsinki, Finland. timo.erkinjuntti@hus.fi
Kurz A
No affiliation info available
Small GW
No affiliation info available
Bullock R
No affiliation info available
Lilienfeld S
No affiliation info available
Damaraju CV
No affiliation info available
GAL-INT-6 Study Group
No affiliation info available

MeSH

AgedAlzheimer DiseaseCerebrovascular DisordersCholinesterase InhibitorsCognitionDementia, VascularDouble-Blind MethodFemaleGalantamineHumansMale

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12860497

Citation

Erkinjuntti, Timo, et al. "An Open-label Extension Trial of Galantamine in Patients With Probable Vascular Dementia and Mixed Dementia." Clinical Therapeutics, vol. 25, no. 6, 2003, pp. 1765-82.
Erkinjuntti T, Kurz A, Small GW, et al. An open-label extension trial of galantamine in patients with probable vascular dementia and mixed dementia. Clin Ther. 2003;25(6):1765-82.
Erkinjuntti, T., Kurz, A., Small, G. W., Bullock, R., Lilienfeld, S., & Damaraju, C. V. (2003). An open-label extension trial of galantamine in patients with probable vascular dementia and mixed dementia. Clinical Therapeutics, 25(6), 1765-82.
Erkinjuntti T, et al. An Open-label Extension Trial of Galantamine in Patients With Probable Vascular Dementia and Mixed Dementia. Clin Ther. 2003;25(6):1765-82. PubMed PMID: 12860497.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An open-label extension trial of galantamine in patients with probable vascular dementia and mixed dementia. AU - Erkinjuntti,Timo, AU - Kurz,Alexander, AU - Small,Gary W, AU - Bullock,Roger, AU - Lilienfeld,Sean, AU - Damaraju,C V, AU - ,, PY - 2003/7/16/pubmed PY - 2003/10/31/medline PY - 2003/7/16/entrez SP - 1765 EP - 82 JF - Clinical therapeutics JO - Clin Ther VL - 25 IS - 6 N2 - BACKGROUND: Alzheimer's disease (AD) and vascular dementia (VaD) are the most common types of dementia worldwide. Galantamine, an acetylcholinesterase inhibitor and allosteric nicotinic modulator, has shown broad clinical benefits in patients with mild to moderate dementia due to AD, probable VaD, or AD with cerebrovascular disease (CVD)-so-called mixed dementia. OBJECTIVE: The purpose of this study was to evaluate the efficacy and safety profiles of galantamine 24 mg/d in patients with VaD or AD with CVD over the longer term (>6 months). METHODS: This was an open-label extension of a 6-month double-blind study of galantamine. Patients who had been randomized to receive galantamine 24 mg/d or placebo in the double-blind phase were eligible to continue open-label treatment with galantamine 24 mg/d for 6 months. The primary efficacy end point was change in cognition, based on scores on the 11-item Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog/11). Secondary measures included changes in functional ability (as measured on the Disability Assessment for Dementia [DAD]) and behavior (as measured on the Neuropsychiatric Inventory [NPI]). Safety and tolerability were also monitored. RESULTS: Four hundred fifty-nine patients (240 men, 219 women; mean [SE] age, 75.2 [0.33] years) entered the open-label phase. Of these patients, 195 (42.5%) had a diagnosis of probable VaD, and 238 (51.9%) had a diagnosis of AD with CVD; the remainder had an inconclusive diagnosis. At month 12 of the study, improvements from baseline (the start of the double-blind phase) in ADAS-cog/11 scores were observed in both the group that received placebo during the double-blind phase (placebo/galantamine group: -0.3 point; 95% CI, -1.64 to 1.06) and the group that received galantamine during the double-blind phase (galantamine/galantamine group: -0.9 point; 95% CI, -1.73 to 0.03). Improvement in functional ability was demonstrated by statistically significant mean (SE) changes from baseline in DAD score in both the placebo/galantamine group (-7.4 [1.68]; P < or = 0.001) and the galantamine/galantamine group (-3.6 [1.33]; P < or = 0.01). There was no significant change in mean (SE) NPI scores in either group (0.2 [0.98] and 0.1 [0.70], respectively). Galantamine treatment was well tolerated. CONCLUSIONS: In these patients with VaD and AD with CVD, galantamine treatment produced similar sustained benefits in terms of maintenance of or improvement in cognition (ADAS-cog/11), functional ability (DAD), and behavior (NPI) after 12 months. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/12860497/An_open_label_extension_trial_of_galantamine_in_patients_with_probable_vascular_dementia_and_mixed_dementia_ DB - PRIME DP - Unbound Medicine ER -