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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