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Table 1 Studies, interventions and patients’ characteristics, and risk of bias of included clinical trials

From: Predictors of discontinuation, efficacy, and safety of memantine treatment for Alzheimer’s disease: meta-analysis and meta-regression of 18 randomized clinical trials involving 5004 patients

Studies

 Number of studiesa

18

 Number of drug-placebo comparisons

19

 Number of patients/study (median) [range]

287 [13–677]

 Multi-site studies (%)

77.8

 Lead-in period (%)

33.3

 Placebo lead-in period (%)

100

 AD severity (%)

  Mild

0

  Mild-moderate

33.3

  Moderate

11.1

  Moderate-severe

55.6

  Severe

0

 Study funding (%)

  Independent

16.7

  Industry

83.3

 ITT statistical analysis (%)

  Discontinuation outcomes

100

  Efficacy cognitive function

56.2

  Efficacy global change

70.0

  Efficacy neuropsychiatric symptoms

14.3

  Efficacy functional ability

60.0

  Safety outcomes

100

Interventionb

 Monotherapy (%)

57.9

 Combination ChEI (%)

42.1

 Dose (%)

  20 mg

94.4

  28 mg

5.6

 Dosage (%)

  Fixed

94.4

  Flexible

5.6

 Regimen (%)

  qd

31.6

  bid

68.4

 Length (mean) [range]

39.1 [12–208]

  12–24weeks (%)

15.8

  v≥24–36 weeks (%)

52.6

  ≥36 weeks (%)

31.6

Patients

 Number of patients

5004

 Age (mean) [range]

75.8 [65.2–84.6]

  <75 years (%)

33.3

  ≥75–77 years (%)

38.9

  ≥77–79 years (%)

22.2

  ≥80 years (%)

5.6

 Women (%) [range]

59.5 [2.9–86.7]

 Baseline cognitive function (mean) c[range]

45.6 [24.3–72.4]

 Baseline severity neuropsychiatric symptoms (mean) c[range]

11.3 [4.4–25.4]

 Baseline functional ability (mean) c[range]

65.7 [50.2–79.6]

Scales of efficacy assessmenta

 Cognitive function

  ADAS-Cog (%)

35.3

  MMSE (%)

41.2

  SIB (%)

23.5

 Global change

  CIBIC-Plus (%)

80.0

  CGI (%)

20.0

 Neuropsychiatric symptoms

  NPI (%)

100

 Functional ability

  ADCS-ADL19 (%)

60.0

  ADCS-ADL23 (%)

40.0

High risk of biasd

 Discontinuation outcomes

0

 Efficacy cognitive function

17.6

 Efficacy global change

10.0

 Efficacy neuropsychiatric symptoms

20.0

 Efficacy functional ability

10.0

 Safety outcomes

0

  1. Abbreviations: AD Alzheimer’s disease, ADAS-Cog Alzheimer’s disease Assessment Scale-Cognitive subscale, ADCS-ADL Alzheimer’s Disease Cooperative Study Activities of Daily Living Inventory 19- or 23-item scale, bid twice a day, CGI Clinical Global Impression, CIBIC-Plus Clinician Interview-Based Impression on Change-Plus Caregiver Input, ITT intention to treat, MMSE Mini-Mental State Examination, NPI Neuropsychiatric Inventory, SIB Severe Impairment Battery, qd once a day
  2. aOne RPCCT included with factorial design
  3. bProportion of drug-placebo comparisons
  4. cAs a percentage of scale maxima (0–100)
  5. dProportion of comparisons with high risk of bias for each outcome