Table A16-25Acetylcholinesterase inhibitors (galantamine) vs. placebo for the treatment of people with mild cognitive impairment

Quality assessmentSummary of findings
No of patientsEffectQualityImportance
No of studiesDesignLimitationsConsistencyDirectnessOther considerationsgalantamineplaceboRelative (95% CI)Absolute (95% CI)
Cognitive symptoms (Mean change on ADAS-Cog at 12 months follow up [LOCF], Range: to . Better indicated by: lower scores)
2Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyNone940963-WMD −0.11 (−0.62 to 0.40)⊕⊕⊕⊕
High
9
Cognitive symptoms (Mean change on ADAS-Cog at 24 months follow up [LOCF], Range: to . Better indicated by: lower scores)
2Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyNone940963-WMD −0.21 (−0.78 to 0.37)⊕⊕⊕⊕
High
9
General cognitive functioning (Mean change on CDR sum of boxes at 12 months [LOCF], Range: to . Better indicated by: lower scores)
2Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyNone940963-WMD −0.10 (−0.21 to 0.01)⊕⊕⊕⊕
High
9
General cognitive functioning (Mean change on CDR sum of boxes at 24 months [LOCF], Range: to . Better indicated by: lower scores)
2Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyNone940963-WMD −0.15 (−0.28 to −0.02)⊕⊕⊕⊕
High
9
Digit symbol substitution (Mean change of the Digit Symbol Substitution Test at 12 months follow up [LOCF], Range: to . Better indicated by: lower scores)
1Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyNone442452-WMD −1.70 (−3.46 to 0.06)⊕⊕⊕⊕
High
9
Digit symbol substitution (Mean change of the Digit Symbol Substitution Test at 24 months follow up [LOCF], Range: to . Better indicated by: lower scores)
1Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyNone442452-WMD −1.00 (−2.92 to 0.92)⊕⊕⊕⊕
High
9
Number converting to dementia (Number with CDR >= 1 by month 24 Follow up: 24 months)
2Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyNone145/940 (15.4%)190/963 (19.7%)RR 0.78 (0.64 to 0.95)40/1 000 (80 to 10)⊕⊕⊕⊕
High
9
Any treatment-emergent adverse event ( Follow up: )
2Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyNone846/940 (90%)837/963 (86.9%)RR 1.04 (1.00 to 1.07)30/1 000 (0 to 60)⊕⊕⊕⊕
High
9
Any treatment-emergent serious adverse event ( Follow up: )
2Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyNone175/940 (18.6%)184/963 (19.1%)RR 0.97 (0.81 to 1.17)0/1 000 ( to )⊕⊕⊕⊕
High
9
AE: Nausea ( Follow up: )
2Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyStrong association (+1)12,277/940 (29.5%)105/963 (10.9%)RR 2.70 (2.20 to 3.32)190/1 000 (150 to 220)⊕⊕⊕⊕
High
9
Mortality (Number of deaths due to treatment-emergent AEs Follow up: )
2Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyVery strong association (+2)13,13/940 (1.4%)1/963 (0.1%)RR 9.22 (1.71 to 49.66)10/1 000 (0 to 20)⊕⊕⊕⊕
High
9
Leaving the study early due to adverse events ( Follow up: )
2Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyStrong association (+1)12,208/940 (22.1%)92/963 (9.6%)RR 2.32 (1.84 to 2.91)130/1 000 (90 to 160)⊕⊕⊕⊕
High
9
1

CI compatible with both benefit and no benefit

2

Random effects model used due to heterogeneity

3

Observed case analysis with higher attrition in the active treatment group

4

One relatively small study

5

ADCS MCI-ADL = Alzheimer's Disease Cooperative Study Mild Cognitive Impairment-Activities of Daily Living Scale

6

Calculated using a random effects model

7

Unless otherwise indicated, negative effect sizes favour active treatment

8

CI compatible with both harm and no harm

9

ADAS-cog = Alzheimer's Disease Assessment Scale - cognitive subscale

10

WMS-R = Wechsler Memory Scale-Revised

11

CGIC-MCI = Clinical Global Impression of Change instrument - for Mild Cognitive Impairment

12

RR > 2, p < .01

13

RR > 5, p < .01

From: APPENDIX 16, EVIDENCE PROFILE TABLES FOR QUANTITATIVE REVIEWS

Cover of Dementia
Dementia: A NICE-SCIE Guideline on Supporting People With Dementia and Their Carers in Health and Social Care.
NICE Clinical Guidelines, No. 42.
National Collaborating Centre for Mental Health (UK).
Leicester (UK): British Psychological Society; 2007.
Copyright © 2007, The British Psychological Society & The Royal College of Psychiatrists.

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