Mini Mental State Examination and Logical Memory scores for entry into Alzheimer’s disease trials

Table 4 PPV and NPV for AD clinical trial and diagnostic study LM-II cutoff scores for normal cognition versus MCI in NACC

	Sensitivity	Specificity	PPV	NPV
LM-II score (A4 Trial) (10,741 normal cognition; 5883 MCI)
Cutoff score = 6	40.5	91.1	71.4	73.6
LM-II score (BAN2401 Trial)
50–64 years (2315 normal cognition; 897 MCI)
Cutoff score = 15	92.1	27.8	33.1	90.1
65–69 years (2092 normal cognition; 909 MCI)
Cutoff score = 12	77.7	52.0	41.3	84.3
70–74 years (2083 normal cognition; 1182 MCI)
Cutoff score = 11	78.1	57.3	50.9	82.1
75–79 years (1824 normal cognition; 1270 MCI)
Cutoff score = 9	67.0	70.0	60.9	75.2
80–90 years (2212 normal cognition; 1472 MCI)
Cutoff score = 7	54.8	80.7	65.4	72.8
LM-II score (ADNI 2)
16+ years of education (6583 normal cognition; 3202 MCI)
Cutoff score = 9	66.4	80.2	62.1	83.0
Cutoff score = 10	73.4	73.0	57.0	84.9
Cutoff score = 11	79.8	64.4	52.2	86.7
8–15 years of education (4061 normal cognition; 2576 MCI)
Cutoff score = 5	35.6	91.3	72.2	69.1
Cutoff score = 6	44.0	86.4	67.2	70.9
Cutoff score = 7	52.5	80.4	62.9	72.7
Cutoff score = 8	60.2	73.1	58.7	74.3
Cutoff score = 9	68.4	64.5	55.0	76.3
0–7 years of education (51 normal cognition; 85 MCI)
Cutoff score = 3	33.7	82.4	76.3	42.4
Cutoff score = 4	44.2	76.5	76	44.8
Cutoff score = 5	54.7	74.5	78.3	49.4

Abbreviations: NACC National Alzheimer’s Coordinating Center, MMSE Mini Mental State Examination, LM-II Wechsler Memory Scale Logical Memory-II, MCI mild cognitive impairment, ADNI 2 Alzheimer’s Disease Neuroimaging Initiative 2, PPV positive predictive value, NPV negative predictive value
PPV and NPV are based on the prevalence of MCI in each of the age or educational categories. Cutoffs were chosen on the basis of those used in AD clinical trials and diagnostic studies: “Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Disease” (6–18 = asymptomatic AD); “A Placebo-controlled, Double-blind, Parallel-group, Bayesian Adaptive Randomization Design and Dose-Regimen-find Study to Evaluate Safety, Tolerability and Efficacy of BAN2401 in Subjects with Early Alzheimer’s Disease” (50–64 years: ≤15; 65–69 years: ≤12; 70–74 years: ≤11; 75–79 years: ≤9; 80–90 years ≤7); and ADNI 2 (16 years of education: normal ≥9; early MCI 9–11; AD ≤8; 8–15 years of education: normal ≥5; early MCI 5–9; AD ≤4; 0–7 years of education: normal ≥3; early MCI 3–6; AD ≤2)

ISSN: 1758-9193