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Neuropsychiatric Disease and Treatment Volume 10, 2014 - Issue
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Original Research

Effects of galantamine in a 2-year, randomized, placebo-controlled study in Alzheimer’s disease

Klaus Hager1 Clinic for Medicine of the Elderly, Hannover, Germany
,
Alan S Baseman2 Janssen Research and Development, LLC, Raritan, NJ, USACorrespondence[email protected]
,
Jeffrey S Nye2 Janssen Research and Development, LLC, Raritan, NJ, USA
,
H Robert Brashear2 Janssen Research and Development, LLC, Raritan, NJ, USA
,
John Han2 Janssen Research and Development, LLC, Raritan, NJ, USA
,
Mary Sano3 The Mount Sinai Medical Center, New York, NY, USA
,
Bonnie Davis4 Synaptec Inc., Palm Beach Gardens, FL, USA
&
Henry M Richards2 Janssen Research and Development, LLC, Raritan, NJ, USA
 show all
Pages 391-401 | Published online: 21 Feb 2014

Figures & data

Figure 1 Patient disposition.

Notes: aUptitration (from 16 mg/day to 24 mg/day) or downtitration (from 24 mg/day to 16 mg/day) of dose was allowed, based on tolerability and the investigator’s judgment. Patients unable to tolerate a minimum of 16 mg/day dose were to discontinue treatment and were followed until the end of the maintenance and posttreatment period. The total number of patients included in the safety analysis set was n=2,045; bearly study termination, per Data Safety Monitoring Board recommendation, when the prespecified number of deaths was ascertained and a significant imbalance favoring galantamine was observed; ca one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and patient tolerability.
Abbreviation: Gal, galantamine.
Figure 1 Patient disposition.

Table 1 Demographic and baseline characteristics (safety analysis set)

Table 2 Extent of exposure to galantamine and placebo

Figure 2 Time from randomization to death (safety analysis set).

Figure 2 Time from randomization to death (safety analysis set).

Table 3 Treatment-emergent adverse events in at least 2% of patients in any treatment group (safety analysis set)

Figure 3 Mean change in MMSE scores over time (LOCF) (ITT analysis set).

Notes: *Significant difference between galantamine and placebo in MMSE score change from baseline. Two sites (049134 and 049137) were excluded from the analysis due to GCP noncompliance. Estimates of treatment differences (95% CIs) of MMSE using the repeated measures model (OC) were: −0.48 (−0.73 to −0.22) at month 6, and −1.10 (−1.67 to −0.52) at month 24.
Abbreviations: CI, confidence interval; GCP, Good Clinical Practice; ITT, intent-to-treat; LOCF, last observation carried forward; MMSE, Mini-Mental State Examination; OC, observed case; SE, standard error.
Figure 3 Mean change in MMSE scores over time (LOCF) (ITT analysis set).

Figure 4 Mean change in DAD scores over time (LOCF) (ITT analysis set).

Notes: *Significant difference between galantamine and placebo in DAD score change from baseline. Two sites (049134 and 049137) were excluded from the analysis due to GCP noncompliance.
Abbreviations: DAD, Disability Assessment in Dementia; GCP, Good Clinical Practice; ITT, intent-to-treat; LOCF, last observation carried forward; SE, standard error.
Figure 4 Mean change in DAD scores over time (LOCF) (ITT analysis set).

Table 4 Analysis of MMSE at month 24 by concomitant use or nonuse of memantine medication (intent-to-treat analysis set)

Table S1 Demographic and baseline characteristics (completers analysis set)

Table S2 Medical history (safety analysis set)

Table S3 Medical history (completer analysis set)

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