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Cessation versus continuation of galantamine treatment after 12 months of therapy in patients with Alzheimer's disease: a randomized, double blind, placebo controlled withdrawal trial.
J Alzheimers Dis. 2011; 26(2):211-20.JA

Abstract

Galantamine improved symptoms in Alzheimer's disease (AD) patients after 5 to 6 months of treatment. To examine long-term outcomes, this study assessed if continuing of galantamine treatment beyond 12 months delayed further cognitive deterioration. It consisted of two phases: an open label (OL) phase (12 months), followed by a double blind, randomized, placebo controlled withdrawal phase (up to 24 months). Subjects with mild to moderate AD were included in the study and titrated up to 16 mg/day of galantamine. Subjects were eligible to enter the double blind phase if a cognitive decline of <4 points on AD Assessment Scale-cognitive subscale (ADAS-cog)/11 was recorded at the end of the OL phase. The differences between galantamine and placebo in time to dropout were estimated using the Cox proportional hazard model. 47.4% of galantamine and 31.7% of placebo subjects completed the double blind phase. Placebo subjects were more likely to discontinue prematurely than galantamine subjects for any reason (hazard ratio [HR] 1.76, 95% confidence interval [CI] 1.10-2.81, p = 0.02), or lack of efficacy (HR 1.80, 95% CI 1.02-3.18, p = 0.04); no statistically significant difference was seen for a change in ADAS-cog ≥ 4 between treatment groups (HR 1.66, 95% CI 0.78-3.54, p = 0.19). Subjects who responded to 12 months of galantamine treatment benefited from continued drug therapy for up to 36 months. Galantamine was effective in delaying time to cognitive deterioration in subjects with mild to moderate AD. Treatment was generally safe and well tolerated.

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Authors+Show Affiliations

Scarpini E
Department of Neurological Sciences, University of Milan, Fondazione Cà Granda, IRCCS Ospedale Maggiore Policlinico, Milan, Italy. elio.scarpini@unimi.it
Bruno G
No affiliation info available
Zappalà G
No affiliation info available
Adami M
No affiliation info available
Richarz U
No affiliation info available
Gaudig M
No affiliation info available
Jacobs A
No affiliation info available
Schäuble B
No affiliation info available

MeSH

AgedAged, 80 and overAlzheimer DiseaseCholinesterase InhibitorsCognitionDouble-Blind MethodFemaleGalantamineHumansMaleMiddle AgedNeuropsychological TestsNootropic AgentsTreatment OutcomeWithholding Treatment

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

21606568

Citation

Scarpini, Elio, et al. "Cessation Versus Continuation of Galantamine Treatment After 12 Months of Therapy in Patients With Alzheimer's Disease: a Randomized, Double Blind, Placebo Controlled Withdrawal Trial." Journal of Alzheimer's Disease : JAD, vol. 26, no. 2, 2011, pp. 211-20.
Scarpini E, Bruno G, Zappalà G, et al. Cessation versus continuation of galantamine treatment after 12 months of therapy in patients with Alzheimer's disease: a randomized, double blind, placebo controlled withdrawal trial. J Alzheimers Dis. 2011;26(2):211-20.
Scarpini, E., Bruno, G., Zappalà, G., Adami, M., Richarz, U., Gaudig, M., Jacobs, A., & Schäuble, B. (2011). Cessation versus continuation of galantamine treatment after 12 months of therapy in patients with Alzheimer's disease: a randomized, double blind, placebo controlled withdrawal trial. Journal of Alzheimer's Disease : JAD, 26(2), 211-20. https://doi.org/10.3233/JAD-2011-110134
Scarpini E, et al. Cessation Versus Continuation of Galantamine Treatment After 12 Months of Therapy in Patients With Alzheimer's Disease: a Randomized, Double Blind, Placebo Controlled Withdrawal Trial. J Alzheimers Dis. 2011;26(2):211-20. PubMed PMID: 21606568.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cessation versus continuation of galantamine treatment after 12 months of therapy in patients with Alzheimer's disease: a randomized, double blind, placebo controlled withdrawal trial. AU - Scarpini,Elio, AU - Bruno,Giuseppe, AU - Zappalà,Giuseppe, AU - Adami,Marina, AU - Richarz,Ute, AU - Gaudig,Maren, AU - Jacobs,Adam, AU - Schäuble,Barbara, PY - 2011/5/25/entrez PY - 2011/5/25/pubmed PY - 2012/1/18/medline SP - 211 EP - 20 JF - Journal of Alzheimer's disease : JAD JO - J Alzheimers Dis VL - 26 IS - 2 N2 - Galantamine improved symptoms in Alzheimer's disease (AD) patients after 5 to 6 months of treatment. To examine long-term outcomes, this study assessed if continuing of galantamine treatment beyond 12 months delayed further cognitive deterioration. It consisted of two phases: an open label (OL) phase (12 months), followed by a double blind, randomized, placebo controlled withdrawal phase (up to 24 months). Subjects with mild to moderate AD were included in the study and titrated up to 16 mg/day of galantamine. Subjects were eligible to enter the double blind phase if a cognitive decline of <4 points on AD Assessment Scale-cognitive subscale (ADAS-cog)/11 was recorded at the end of the OL phase. The differences between galantamine and placebo in time to dropout were estimated using the Cox proportional hazard model. 47.4% of galantamine and 31.7% of placebo subjects completed the double blind phase. Placebo subjects were more likely to discontinue prematurely than galantamine subjects for any reason (hazard ratio [HR] 1.76, 95% confidence interval [CI] 1.10-2.81, p = 0.02), or lack of efficacy (HR 1.80, 95% CI 1.02-3.18, p = 0.04); no statistically significant difference was seen for a change in ADAS-cog ≥ 4 between treatment groups (HR 1.66, 95% CI 0.78-3.54, p = 0.19). Subjects who responded to 12 months of galantamine treatment benefited from continued drug therapy for up to 36 months. Galantamine was effective in delaying time to cognitive deterioration in subjects with mild to moderate AD. Treatment was generally safe and well tolerated. SN - 1875-8908 UR - https://www.unboundmedicine.com/medline/citation/21606568/Cessation_versus_continuation_of_galantamine_treatment_after_12_months_of_therapy_in_patients_with_Alzheimer's_disease:_a_randomized_double_blind_placebo_controlled_withdrawal_trial_ L2 - https://content.iospress.com/openurl?genre=article&amp;id=doi:10.3233/JAD-2011-110134 DB - PRIME DP - Unbound Medicine ER -