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Galantamine treatment of vascular dementia: a randomized trial.
Neurology. 2007 Jul 31; 69(5):448-58.Neur

Abstract

BACKGROUND

To evaluate efficacy and safety of galantamine for patients with vascular dementia (VaD).

METHODS

In this multinational, randomized, double-blind, placebo-controlled, parallel-group clinical trial, 788 patients with probable VaD who also satisfied strict centrally read MRI criteria were randomized to receive galantamine or placebo. Efficacy was evaluated using measures of cognition, daily function, and behavior. The primary efficacy measures were the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog/11) and the Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL) total score. Secondary outcomes included the Clinician's Interview Based on Impression of Change-Plus Caregiver Input (CIBIC-plus), Neuropsychiatric Inventory, and EXIT-25 for assessment of executive functioning. Safety and tolerability were also monitored.

RESULTS

Patients treated with galantamine had a greater improvement in ADAS-cog/11 after 26 weeks compared with placebo (-1.8 vs -0.3; p < 0.001). There was no difference between galantamine and placebo at week 26 on the ADCS-ADL score (0.7 vs 1.3; p = 0.783). Improvement in global functioning measured by the CIBIC-plus associated with galantamine approached significance (p = 0.069). A difference between treatment groups for EXIT-25 favoring galantamine was detected (p = 0.041). Safety data revealed that 13% of galantamine and 6% of placebo patients discontinued treatment because of adverse events.

CONCLUSIONS

Significance was not reached for both co-primary endpoints. Galantamine was effective for improving cognition, including executive function, in patients with vascular dementia, with good safety and tolerability. However, improvement in activities of daily living with galantamine was similar to that observed with placebo.

Authors+Show Affiliations

Auchus AP
University of Tennessee Health Science Center, Department of Neurology, Memphis, TN 38163, USA. aauchus@utmem.edu
Brashear HR
No affiliation info available
Salloway S
No affiliation info available
Korczyn AD
No affiliation info available
De Deyn PP
No affiliation info available
Gassmann-Mayer C
No affiliation info available
GAL-INT-26 Study Group
No affiliation info available

MeSH

AcetylcholineActivities of Daily LivingAdultAgedBehavioral SymptomsBrainBrain ChemistryCholinesterase InhibitorsCognitionCognition DisordersDementia, VascularDouble-Blind MethodFemaleGalantamineHumansMaleMiddle AgedNeuropsychological TestsPlacebosRecovery of FunctionTreatment Outcome

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

17664404

Citation

Auchus, A P., et al. "Galantamine Treatment of Vascular Dementia: a Randomized Trial." Neurology, vol. 69, no. 5, 2007, pp. 448-58.
Auchus AP, Brashear HR, Salloway S, et al. Galantamine treatment of vascular dementia: a randomized trial. Neurology. 2007;69(5):448-58.
Auchus, A. P., Brashear, H. R., Salloway, S., Korczyn, A. D., De Deyn, P. P., & Gassmann-Mayer, C. (2007). Galantamine treatment of vascular dementia: a randomized trial. Neurology, 69(5), 448-58.
Auchus AP, et al. Galantamine Treatment of Vascular Dementia: a Randomized Trial. Neurology. 2007 Jul 31;69(5):448-58. PubMed PMID: 17664404.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Galantamine treatment of vascular dementia: a randomized trial. AU - Auchus,A P, AU - Brashear,H R, AU - Salloway,S, AU - Korczyn,A D, AU - De Deyn,P P, AU - Gassmann-Mayer,C, AU - ,, PY - 2007/8/1/pubmed PY - 2007/8/25/medline PY - 2007/8/1/entrez SP - 448 EP - 58 JF - Neurology JO - Neurology VL - 69 IS - 5 N2 - BACKGROUND: To evaluate efficacy and safety of galantamine for patients with vascular dementia (VaD). METHODS: In this multinational, randomized, double-blind, placebo-controlled, parallel-group clinical trial, 788 patients with probable VaD who also satisfied strict centrally read MRI criteria were randomized to receive galantamine or placebo. Efficacy was evaluated using measures of cognition, daily function, and behavior. The primary efficacy measures were the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog/11) and the Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL) total score. Secondary outcomes included the Clinician's Interview Based on Impression of Change-Plus Caregiver Input (CIBIC-plus), Neuropsychiatric Inventory, and EXIT-25 for assessment of executive functioning. Safety and tolerability were also monitored. RESULTS: Patients treated with galantamine had a greater improvement in ADAS-cog/11 after 26 weeks compared with placebo (-1.8 vs -0.3; p < 0.001). There was no difference between galantamine and placebo at week 26 on the ADCS-ADL score (0.7 vs 1.3; p = 0.783). Improvement in global functioning measured by the CIBIC-plus associated with galantamine approached significance (p = 0.069). A difference between treatment groups for EXIT-25 favoring galantamine was detected (p = 0.041). Safety data revealed that 13% of galantamine and 6% of placebo patients discontinued treatment because of adverse events. CONCLUSIONS: Significance was not reached for both co-primary endpoints. Galantamine was effective for improving cognition, including executive function, in patients with vascular dementia, with good safety and tolerability. However, improvement in activities of daily living with galantamine was similar to that observed with placebo. SN - 1526-632X UR - https://www.unboundmedicine.com/medline/citation/17664404/Galantamine_treatment_of_vascular_dementia:_a_randomized_trial_ DB - PRIME DP - Unbound Medicine ER -