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

Table 6 PPV and NPV for AD clinical trial and diagnostic study LM-II cutoff scores for MCI versus AD dementia in NACC

	Sensitivity	Specificity	PPV	NPV
LM-II score (A4 Trial) (5883 MCI; 6814 AD dementia)
Cutoff score = 6	89.0	51.8	68.1	80.3
LM-II score (BAN2401 Trial)
50–64 years (897 MCI; 995 AD dementia)
Cutoff score = 15	99.4	5.3	53.9	88.9
65–69 years (909 MCI; 722 AD dementia)
Cutoff score = 12	98.5	16.2	48.2	93.1
70–74 years (1182 MCI; 1082 AD dementia)
Cutoff score = 11	97.3	15.9	51.5	86.7
75–79 years (1270 MCI; 1562 AD dementia)
Cutoff score = 9	96.2	26.2	61.5	85.0
80–90 years (1472 MCI; 2263 AD dementia)
Cutoff score = 7	93.9	37.8	69.8	80.2
LM-II score (ADNI 2)
16+ years of education (3202 MCI; 3118 AD dementia)
Cutoff score = 8	92.4	48.3	63.5	86.8
8–15 years of education (2576 MCI; 3518 AD dementia)
Cutoff score = 4	84.4	64.4	76.4	75.1
0–7 years of education (85 MCI; 143 AD dementia)
Cutoff score = 2	77.8	66.3	79.6	64.0

Abbreviations: NACC National Alzheimer’s Coordinating Center, MMSE Mini Mental State Examination, MCI mild cognitive impairment, LM-II Wechsler Memory Scale Logical Memory-II, 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 AD dementia 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)

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