Research diagnostic criteria for Alzheimer’s disease: findings from the LipiDiDiet randomized controlled trial

Table 3 Two-year change from baseline in NTB and CDR-SB scores and progression to dementia according to the IWG-2, NIA-AA 2011, and NIA-AA 2018 criteria

	N with data	Change in NTB composite		Change in NTB memory		Change in NTB executive functioning		Change in NTB total		Change in CDR-SB		Progression to dementia
	N with data	Estimate	p	Estimate	p	Estimate	p	Estimate	p	Estimate	p	N (%)	HR (95% CI)
IWG-2
No prodromal AD	24	−0.018	Ref	−0.004	Ref	−0.085	Ref	0.048	Ref	0.42	Ref	7/26 (26.9)	Ref
Prodromal AD	76	−0.254	0.11	−0.266	0.11	−0.097	0.93	−0.107	0.13	1.18	0.03	34/81 (42.0)	4.6 (1.6–13.7)
NIA-AA 2011
SNAP	13	0.081	Ref	0.128	Ref	−0.044	Ref	0.057	Ref	0.56	Ref	1/13 (7.7)	Ref
Inconclusive/uninformative	22	0.129	0.79	0.087	0.85	0.014	0.75	0.109	0.71	0.21	0.51	4/25 (16.0)	2.0 (0.2–18.7)
Intermediate AD likelihood	135	−0.192	0.07	−0.209	0.06	−0.144	0.50	−0.169	0.05	1.29	0.08	64/155 (41.3)	6.8 (0.9–50.0)
High AD likelihood	86	−0.195	0.08	− 0.186	0.08	−0.083	0.80	−0.084	0.23	1.08	0.23	40/93 (43.0)	7.4 (1.0–54.7)
NIA-AA 2018
Non-Alzheimer’s pathologic change	13	0.057	Ref	0.049	Ref	−0.088	Ref	0.038	Ref	0.48	Ref	1/13 (7.7)	Ref
Alzheimer’s and concomitant suspected non-Alzheimer’s pathologic change	22	−0.154	0.31	−0.125	0.45	−0.112	0.91	0.029	0.96	0.43	0.91	10/25 (40.0)	3.5 (0.4–29.4)
AD	64	−0.274	0.08	−0.299	0.09	−0.087	0.99	−0.134	0.20	1.43	0.03	30/68 (44.1)	9.4 (1.2–72.7)

Estimates for change in NTB and CDR-SB scores are least-squares means for change from baseline over 2 years within each group. Negative values indicate decline over time, except for CDR-SB where positive values indicate decline. p-values are shown for the difference in the least-squares means over 2 years between each group and the respective reference group. Numbers of participants are as per modified intention-to-treat (mITT) analysis. CDR-SB data were missing for nine participants (IWG-2, NIA-AA 2018) and 32 participants (NIA-AA 2011). Isolate amyloid pathology/Alzheimer’s pathologic change was excluded from the analyses (N = 1)
Abbreviations: AD, Alzheimer’s disease; CDR-SB, Clinical Dementia Rating-Sum of Boxes; IWG, International Working Group; NIA-AA, National Institute on Aging–Alzheimer’s Association; NTB, Neuropsychological Test Battery; SNAP, suspected non-AD pathology

ISSN: 1758-9193