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Meta-Analysis
. 2006 Jan 25;2006(1):CD001747.
doi: 10.1002/14651858.CD001747.pub3.

Galantamine for Alzheimer's disease and mild cognitive impairment

C Loy  1 , L Schneider
Affiliations
Meta-Analysis

Galantamine for Alzheimer's disease and mild cognitive impairment

C Loy et al. Cochrane Database Syst Rev. .

Update in

Abstract

Background: Galantamine is a specific, competitive, and reversible acetylcholinesterase inhibitor.

Objectives: To assess the clinical effects of galantamine in patients with mild cognitive impairment (MCI), probable or possible Alzheimer's disease (AD), and potential moderators of effect.

Search strategy: The trials were identified from a search of the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group, last updated on 25 April 2005 using the terms galanthamin*, galantamin* and Reminyl. Published reviews were inspected for further sources. Additional information was collected from unpublished clinical research reports for galantamine obtained from Janssen and from http://www.clinicalstudyresults.org/.

Selection criteria: Trials selected were randomised, double-blind, parallel-group comparisons of galantamine with placebo for a treatment duration of greater than 4 weeks in subjects with MCI or AD.

Data collection and analysis: Data were extracted independently by the reviewers and pooled where appropriate and possible. Outcomes of interest include the clinical global impression of change (CIBIC-plus or CGIC), Alzheimer's Disease Assessment Scale-cognitive sub scale (ADAS-cog), Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL), Disability Assessment for Dementia scale (DAD) and Neuropsychiatric Inventory (NPI). Potential moderating variables of treatment effect assessed included trial duration, dose, and diagnosis of possible versus probable Alzheimer's disease.

Main results: Ten trials with a total 6805 subjects were included in the analysis. Treatment with galantamine led to a significantly greater proportion of subjects with improved or unchanged global rating scale rating (k = 8 studies), at all dosing levels except for 8 mg/d . Confidence intervals for the ORs overlapped across the dose range of 16 mg to 36 mg per day, with point estimates of 1.6 - 1.8 when analysed with the intention-to-treat sample. Treatment with galantamine also led to significantly greater reduction in ADAS-cog score at all dosing levels (k = 8), with greater effect over six months compared to three months. Confidence intervals again overlapped. Point estimate of effect was lower for 8 mg/d but similar for 16 mg to 36 mg per day. For example, treatment effect for 24 mg/d over six months was 3.1 point reduction in ADAS-cog (95%CI 2.6-3.7, k = 4, ITT).ADCS-ADL, DAD and NPI were reported only in a small proportion of trials: all showed significant treatment effect in some individual trials at least. Confidence interval of treatment effect for the one trial recruiting patients with possible AD overlapped with the other seven recruiting patients with probable AD. Galantamine's adverse effects appeared similar to those of other cholinesterase inhibitors and to be dose related. Prolong release / once daily formulation of galantamine at 16 - 24mg/d was found to have similar efficacy and side-effect profile as the equivalent twice-daily regime. Data from the two MCI trials suggest marginal clinical benefit, but a yet unexplained excess in death rate.

Authors' conclusions: Subjects in these trials were similar to those seen in earlier anti dementia AD trials, consisting primarily of mildly to moderately impaired outpatients. Galantamine's effect on more severely impaired subjects has not yet been assessed.Nevertheless, this review shows consistent positive effects for galantamine for trials of three to six months' duration. Although there was not a statistically significant dose-response effect, doses above 8 mg/d were, for the most part, consistently statistically significant. Galantamine's safety profile in AD is similar to that of other cholinesterase inhibitors with respect to cholinergically mediated gastrointestinal symptoms. It appears that doses of 16 mg/d were best tolerated in the single trial where medication was titrated over a four week period, and because this dose showed statistically indistinguishable efficacy with higher doses, it is probably most preferable initially. Longer term use of galantamine has not been assessed in a controlled fashion. Galantamine use in MCI is not recommended due to its association with an excess death rate.

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Conflict of interest statement

Dr. Schneider and the University of Southern California have received clinical trials‐and other contracts from Janssen Pharmaceutica and Johnson and Johnson, Inc. Dr. Schneider has served as a consultant to Janssen, Pfizer, and Novartis, all manufacturers of cholinesterase inhibitors used to treat AD, and to Forest Pharmaceuticals, manufacturer of memantine used to treat AD, for which he received payments. Dr. Loy has received a Wellcome Trust Travelling Award in relation to his work with the Cochrane Collaboration.

Figures

1.1
1.1. Analysis
Comparison 1 Global Rating OC, Outcome 1 Global Rating (no change or improvement at 3 months) OC.
1.2
1.2. Analysis
Comparison 1 Global Rating OC, Outcome 2 Global Rating (no change or improvement at 6 months) OC.
2.1
2.1. Analysis
Comparison 2 ADAS‐cog (Change from baseline) OC, Outcome 1 ADAS‐cog (Change from baseline at 3 months) OC.
2.2
2.2. Analysis
Comparison 2 ADAS‐cog (Change from baseline) OC, Outcome 2 ADAS‐cog (Change from baseline at 6 months) OC.
3.1
3.1. Analysis
Comparison 3 ADAS‐cog (4 points or more improvement) OC, Outcome 1 ADAS‐cog (4 points or more improvement at 3 months) OC.
3.2
3.2. Analysis
Comparison 3 ADAS‐cog (4 points or more improvement) OC, Outcome 2 ADAS‐cog (4 points or more improvement at 6 months) OC.
4.1
4.1. Analysis
Comparison 4 ADCS‐ADL (Change from baseline) OC, Outcome 1 ADCS/ADL (Change from baseline at 6 months) OC.
5.1
5.1. Analysis
Comparison 5 NPI (Change from baseline) OC, Outcome 1 NPI (Change from baseline at 3 months) OC.
5.2
5.2. Analysis
Comparison 5 NPI (Change from baseline) OC, Outcome 2 NPI (Change from baseline at 6 months) OC.
6.1
6.1. Analysis
Comparison 6 DAD (Change from baseline) OC, Outcome 1 DAD (Change from baseline at 3 months) OC.
6.2
6.2. Analysis
Comparison 6 DAD (Change from baseline) OC, Outcome 2 DAD (Change from baseline at 6 months) OC.
7.1
7.1. Analysis
Comparison 7 Global Rating ITT, Outcome 1 Global Rating (no change or improvement at 3 months) ITT.
7.2
7.2. Analysis
Comparison 7 Global Rating ITT, Outcome 2 Global Rating (no change or improvement at 6 months) ITT.
8.1
8.1. Analysis
Comparison 8 ADAS‐cog (Change from baseline) ITT, Outcome 1 ADAS‐cog (Change from baseline at 3 months) ITT.
8.2
8.2. Analysis
Comparison 8 ADAS‐cog (Change from baseline) ITT, Outcome 2 ADAS‐cog (Change from baseline at 6 months) ITT.
8.3
8.3. Analysis
Comparison 8 ADAS‐cog (Change from baseline) ITT, Outcome 3 ADAS‐cog (Change from baseline at 12 months in MCI) ITT.
8.4
8.4. Analysis
Comparison 8 ADAS‐cog (Change from baseline) ITT, Outcome 4 ADAS‐cog (Change from baseline at 24 months in MCI) ITT.
9.1
9.1. Analysis
Comparison 9 ADAS‐cog (4 point or more improvement) ITT, Outcome 1 ADAS‐cog (4 points or more improvement at 3 months) OC.
10.1
10.1. Analysis
Comparison 10 ADCS‐ADL (Change from baseline) ITT, Outcome 1 ADCS/ADL (Change from baseline at 6 months) ITT.
11.1
11.1. Analysis
Comparison 11 NPI (Change from baseline) ITT, Outcome 1 NPI (Change from baseline at 3 months) ITT.
11.2
11.2. Analysis
Comparison 11 NPI (Change from baseline) ITT, Outcome 2 NPI (Change from baseline at 6 months) ITT.
12.1
12.1. Analysis
Comparison 12 DAD (Change from baseline) ITT, Outcome 1 DAD (Change from baseline at 3 months) ITT.
12.2
12.2. Analysis
Comparison 12 DAD (Change from baseline) ITT, Outcome 2 DAD (Change from baseline at 6 months) ITT.
13.1
13.1. Analysis
Comparison 13 Global Rating dose analyses OC, Outcome 1 Global Rating (no change or improvement; 8 mg) OC.
13.2
13.2. Analysis
Comparison 13 Global Rating dose analyses OC, Outcome 2 Global Rating (no change or improvement 16‐24mg/d) OC.
13.3
13.3. Analysis
Comparison 13 Global Rating dose analyses OC, Outcome 3 Global Rating (no change or improvement 24mg/d to 24‐32mg/d) OC.
13.4
13.4. Analysis
Comparison 13 Global Rating dose analyses OC, Outcome 4 Global Rating (no change or improvement 32‐36mg/d) OC.
14.1
14.1. Analysis
Comparison 14 Global Rating dose analyses ITT, Outcome 1 Global Rating (no change or improvement; 8 mg) ITT.
14.2
14.2. Analysis
Comparison 14 Global Rating dose analyses ITT, Outcome 2 Global Rating (no change or improvement 16‐24mg/d) ITT.
14.3
14.3. Analysis
Comparison 14 Global Rating dose analyses ITT, Outcome 3 Global Rating (no change or improvement 24mg/d to 24‐32mg/d) ITT.
14.4
14.4. Analysis
Comparison 14 Global Rating dose analyses ITT, Outcome 4 Global Rating (no change or improvement 32‐36mg/d) ITT.
15.2
15.2. Analysis
Comparison 15 Conversion from MCI to dementia (change of CDR‐SB from 0.5 to >=1) ITT, Outcome 2 Conversion from MCI to dementia at 24 months.
16.1
16.1. Analysis
Comparison 16 Withdrawals before end of treatment, Outcome 1 Proportion of all cause discontinuations (3 months).
16.2
16.2. Analysis
Comparison 16 Withdrawals before end of treatment, Outcome 2 Proportion of discontinuations due to adverse events (3 months).
16.3
16.3. Analysis
Comparison 16 Withdrawals before end of treatment, Outcome 3 Proportion of all cause discontinuations (6 months).
16.4
16.4. Analysis
Comparison 16 Withdrawals before end of treatment, Outcome 4 Proportion of discontinuations due to adverse events (6 months).
17.1
17.1. Analysis
Comparison 17 Specific adverse events (3 months), Outcome 1 Proportion of subjects experiencing nausea (3 months).
17.2
17.2. Analysis
Comparison 17 Specific adverse events (3 months), Outcome 2 Proportion of subjects experiencing vomiting (3 months).
17.3
17.3. Analysis
Comparison 17 Specific adverse events (3 months), Outcome 3 Proportion of subjects experiencing dizziness (3 months).
17.4
17.4. Analysis
Comparison 17 Specific adverse events (3 months), Outcome 4 Proportion of subjects experiencing diarrhea (3 months).
17.5
17.5. Analysis
Comparison 17 Specific adverse events (3 months), Outcome 5 Proportion of subjects experiencing anorexia (3 months).
17.6
17.6. Analysis
Comparison 17 Specific adverse events (3 months), Outcome 6 Proportion of subjects experiencing somnolence (3 months).
17.7
17.7. Analysis
Comparison 17 Specific adverse events (3 months), Outcome 7 Proportion of subjects experiencing abdominal pain (3 months).
17.8
17.8. Analysis
Comparison 17 Specific adverse events (3 months), Outcome 8 Proportion of subjects experiencing decreased appetite (3 months).
17.9
17.9. Analysis
Comparison 17 Specific adverse events (3 months), Outcome 9 Proportion of subjects experiencing agitation (3 months).
17.10
17.10. Analysis
Comparison 17 Specific adverse events (3 months), Outcome 10 Proportion of subjects experiencing headache (3 months).
18.1
18.1. Analysis
Comparison 18 Specific adverse events (6 months), Outcome 1 Proportion of subjects experiencing nausea (6 months).
18.2
18.2. Analysis
Comparison 18 Specific adverse events (6 months), Outcome 2 Proportion of subjects experiencing vomiting (6 months).
18.3
18.3. Analysis
Comparison 18 Specific adverse events (6 months), Outcome 3 Proportion of subjects experiencing dizziness (6 months).
18.4
18.4. Analysis
Comparison 18 Specific adverse events (6 months), Outcome 4 Proportion of subjects experiencing diarrhea (6 months).
18.5
18.5. Analysis
Comparison 18 Specific adverse events (6 months), Outcome 5 Proportion of subjects experiencing anorexia (6 months).
18.6
18.6. Analysis
Comparison 18 Specific adverse events (6 months), Outcome 6 Proportion of subjects experiencing weight loss (6 months).
18.7
18.7. Analysis
Comparison 18 Specific adverse events (6 months), Outcome 7 Proportion of subjects experiencing abdominal pain (6 months).
18.8
18.8. Analysis
Comparison 18 Specific adverse events (6 months), Outcome 8 Proportion of subjects experiencing tremor (6 months).
18.9
18.9. Analysis
Comparison 18 Specific adverse events (6 months), Outcome 9 Proportion of subjects experiencing agitation (6 months).
18.10
18.10. Analysis
Comparison 18 Specific adverse events (6 months), Outcome 10 Proportion of subjects experiencing headache (6 months).
19.1
19.1. Analysis
Comparison 19 Proportion of subjects deceased, Outcome 1 Proportion of subjects deceased ( 3 months).
19.2
19.2. Analysis
Comparison 19 Proportion of subjects deceased, Outcome 2 Proportion of subjects deceased ( 6 months).
19.3
19.3. Analysis
Comparison 19 Proportion of subjects deceased, Outcome 3 Proportion of subjects deceased ( 24 months in MCI).
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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GAL‐MCI‐301 2004 {published data only}
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Lilienfeld 2001 {published data only}
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Lyketsos 2002 {published data only}
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Scott 2000 {published data only}
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Truyen 2000b {published data only}
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Truyen 2001 {published data only}
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References to ongoing studies

Galantamine CFIDS {published data only (unpublished sought but not used)}
    1. Not reported. Ongoing study Jan 29 1999.
Wilcock {published data only (unpublished sought but not used)}
    1. The safety and efficacy of Galanthamine in the treatment of vascular and mixed dementia. Ongoing study 1 Oct 1998.

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