Donepezil, rivastigmine, galantamine and memantine for ...

TABLE 24 Characteristics of included studies for galantamine
© Queen’s Printer and Controller of HMSO 2006. All rights reserved.
Health Technology Assessment 2006; Vol. 10: No. 1
Study Methods Participants Outcomes
[Commercial/academic confidential information removed]
Raskind et al.,
2000 61
Rockwood et al.,
2001 62
Tariot et al.,
2000 63
Cummings et al.,
2004 67
Wilcock et al.,
2000 64
Design: multicentre, double-blind
RCT
Interventions:
1. Galantamine 24 mg/day
2. Galantamine 32 mg/day
3. Placebo
Number of centres: 33
Duration of treatment: 6 months
Sponsor: Janssen Research Foundation
Design: multicentre, double-blind
RCT
Interventions:
1. Galantamine 24–32 mg/day
2. Placebo
Number of centres: 43
Duration of treatment: 3 months
Sponsor: Janssen Research Foundation
Design: multicentre, double-blind
RCT
Interventions:
1. Galantamine 8 mg/day
2. Galantamine 16 mg/day
3. Galantamine 24 mg/day
4. Placebo
Number of centres: 5
Duration of treatment: 5 months
Sponsor: Janssen Research Foundation
Design: multicentre, double-blind
RCT
Interventions:
1. Galantamine 24 mg/day
2. Galantamine 32 mg/day
3. Placebo
Number of centres: 86
Duration of treatment: 6 months
Sponsor: Janssen Research Foundation
Inclusion criteria: probable AD
(NINCDS-ADRDA); MMSE score
of 11–24; ≥ 12 on ADAS-cog
Numbers: 636 randomised
1. 212 to 24 mg/day
2. 211 to 32 mg/day
3. 213 to placebo
Mean age:
1. 75.9 ± 0.5
2. 75.0 ± 0.6
3. 75.3 ± 0.6
Inclusion criteria: probable AD
(NINCDS-ADRDA); MMSE score
of 11–24 and ≥ 2 on ADAS-cog.
Numbers: 386 randomised.
1. 261 to galantamine (72 final
dose 24 mg/day, 103 final dose
32 mg/day)
2. 125 to placebo
Mean age:
1. 75.2 (0.45)
2. 74.6 (0.68)
Inclusion criteria: probable AD
(NINCDS-ADRDA); MMSE score
10–22, ADAS-cog score of ≥ 18
(from standard 11-item cognitive
subscale).
Numbers: 978 randomised
1. 140 to 8 mg/day
2. 279 to 16 mg/day
3. 273 to 24 mg/day
4. 286 to placebo
Mean age:
1. 76.0 ± 0.6
2. 76.3 ± 0.5
3. 77.7 ± 0.4
4. 77.1 ± 0.5
Inclusion criteria: probable AD
(NINCDS-ADRDA); MMSE score
11–24 and a score of ≥ 12 on
ADAS-cog/11 scale
Numbers: 653 randomised:
1. 220 to 24 mg/day
2. 218 to 32 mg/day
3. 215 to placebo
Mean age:
1. 71.9 (8.3)
2. 72.1 (8.6)
3. 72.2 (7.6)
Primary:
● ADAS-cog/11
● CIBIC-plus
Secondary:
● ADAS-cog/13
● Proportion of responders
on ADAS-cog/11
● DAD
● Adverse events
Primary:
● ADAS-cog/11
● CIBIC-plus
Secondary:
● Expanded ADAS-cog/13
● Proportions of responders
(defined as improvements
in ADAS-cog/11 ≥ 4 points
from baseline)
● NPI
● DAD
● Adverse events
Primary:
● ADAS-cog/11
● CIBIC-plus
Secondary:
● Responders on ADAS-cog
(≥ 4 points relative to
baseline)
● Proportion improved by
≥ 7 points on the ADAScog
● AD Cooperative Study
Activities of Daily Living
inventory (ADCS/ADL)
● NPI
● Adverse events
Primary:
● ADAS-cog/11
● CIBIC-plus
Secondary:
● ADAS-cog/13
● Proportion improving on
ADAS-cog/11 (≥ 0 and ≥ 4
points)
● DAD scale
● Adverse events
continued
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