Table 1.

Clinical trial features of the phase II and III trials of approved agents, donanemab (under review) and remternetug (data from ClinicalTrials.gov; completed and on-going studies are included)

Agent	Trial NCT	Phase	Status	No. of participants	Treatment duration (weeks)	Baseline MMSE (range)	Primary outcome	Secondary clinical outcomes	Biomarker outcomes
Aducanumab	03639987	II	Terminated	52	54	24 and 30	ARIA	10 measures about the onset of ARIA	PET ARIA
Aducanumab	02477800	III	Terminated [2]	1653	78	24 and 30	CDR-SB	MMSE; ADAS-Cog 13; ADCS-ADL-MCI	Amyloid PET SUVR, amyloid PET centiloid, CSF p-tau and t-tau, plasma p-tau
Aducanumab	02484547	III	Terminated [2]	1638	78	24 and 30	CDR-SB	MMSE; ADAS-Cog 13; ADCS-ADL-MCI	Amyloid PET SUVR, amyloid PET centiloid, CSF p-tau and t-tau, plasma p-Tau
Aducanumab	04241068	III	Active, not recruiting	1696	100	NA	No. of participants with AEs, SAEs, AEs leading to treatment discontinuation or study withdrawal, ARIA-E, ARIA-H	NA	PET ARIA
Donanemab	03367403	II	Completed [5]	272	76	20–28	iADRS	ADAS-Cog13; CDR-SB; MMSE; ADCS-iADL	Amyloid PET; Tau PET; vMRI
Donanemab	04437511 [66]	III	Active, not recruiting	1800	76	20–28	iADRS	MMSE; ADAS-Cog13; CDR-SB; ADCS-iADL	Amyloid PET; Tau PET; vMRI; serum concentration; ADA
Donanemab	05026866	III	Recruiting	3300	182	NA	CDR-GS	ISLT; CPAL; iDSSTm; Category fluency; FNAME; BPS-O; CBB; CDR-SB; CFI; MoCA	Serum concentration; ADAs
Donanemab	05108922	III	Active, not recruiting	200	72	20–30	Plaque clearance	None	Amyloid PET
Donanemab	05508789	III	Recruiting	1500	76	20–28	iADRS	CDR-SB; ADAS-Cog; ADCS-iADL; MMSE; QoL; RUD-Lite; NPI	Amyloid PET; ADAs
Donanemab	05738486	III	Recruiting	800	76	20–28	ARIA-E	None	ARIA-E; ARIA-H; serum concentration; ADAs
Lecanemab	01767311	IIb	Active, not recruiting [3]	856	76 (261 extension)	22–30	ADCOMS (12-month)	ADCOMS (18-month); CDR-SB; ADAS-Cog	Amyloid PET; vMRI; CSF (Aβ1-42, t-tau, p-tau)
Lecanemab	03887455	III	Active, not recruiting [4]	1795	76 (300 extension)	22–30	CDR-SB	ADAS-Cog14; ADCOMS; ADCS-ADL-MCI	Amyloid PET; Tau PET; vMRI; CSF (Aβ1-42, t-tau, p-tau, neurogranin, NfL, Aβ1-40); plasma (Aβ42/40 ratio, p-tau, GFAP, NfL)
Lecanemab	04468659	III	Recruiting	1400	216	27–30	PACC5	CFI	Amyloid PET; Tau PET
Lecanemab + E2814	05269394	II/III	Recruiting	168	208	NA	Tau PET	CDR-SB; CCS	Amyloid PET; CSF (NfL, p-tau217/t-tau ratio)
Remternetug	05463731	III	Recruiting	600	52 (and 52 extension)	20–28	Plaque clearance	None	Amyloid PET; ADAs; Cmin

ADA antidrug antibodies, ADAS-Cog Alzheimer’s Disease Assessment Scale–Cognitive Subscale, ADCOMS Alzheimer’s Disease Composite Score, ADCS-ADL-MCI Alzheimer’s Disease Cooperative Study–Activities of Daily Living for Mild Cognitive Impairment, ADCS-iADL Alzheimer’s Disease Cooperative Study Instrumental Activities of Daily Living, AEs adverse events, ARIA amyloid-related imaging abnormalities, ARIA-E amyloid-related imaging abnormalities, effusion/edema, ARIA-H amyloid-related imaging abnormalities, hemorrhagic, BPS-O Behavioral Pattern Separation-Object test, CBB Cogstate Brief Battery, CCS Comprehensive Coordination Scale, CDR-GS Clinical Dementia Rating-Global Score, CDR-SB Clinical Dementia Rating–Sum of Boxes, CFI Cognitive Function Index, C_min trough serum concentration, CPAL Continuous Paired Associate Learning, CSF cerebrospinal fluid, FNAME Face Name Association Test, GFAP glial fibrillary acidic protein, iADRS integrated Alzheimer’s Disease Rating Scale, iDSSTm International Daily Substitution Test-Medicines, ISLT International Shopping List Test, MMSE Mini-Mental State Examination, MoCA Montreal Cognitive Assessment, NA not available, NCT National Clinical Trials, NfL neurofilament light, NPI Neuropsychiatric Inventory, PACC5 Preclinical Alzheimer’s Cognitive Composite-5, PET positron emission tomography, QoL quality of life, RUD-Lite Resource Utilization in Dementia, light version, SAEs serious adverse events, SUVR standardized uptake value ratio, vMRI volumetric magnetic resonance imaging