TABLE 7.

Trial entry criteria and primary outcome measures for Phase 2/3 and 3 disease‐modifying therapies trials (ClinicalTrials.gov accessed February 27, 2020)

Agent	Sponsor	CT.gov ID	Trial name	Subject population	MMSE	Primary outcome assessment tool
Aducanumab	Biogen	NCT04241068	EMBARK	MCI due to AD or mild AD	—	Safety
AGB101	AgeneBio, NIA	NCT03486938	HOPE4MCI	MCI due to AD	24–30	CDR‐SB
ALZT‐OP1	AZTherapies	NCT02547818	COGNITE	Early AD	—	CDR‐SB
ANAVEX2‐73 (blarcamesine)	Anavex Life Sciences	NCT03790709	ANAVEX2‐73‐AD‐004	MCI due to AD or mild AD	20–28	ADAS‐Cog, ADCS‐ADL
Azeliragon	vTv therapeutics	NCT03980730	Elevage	Mild AD with elevated HbA1c	21–26	ADAS‐Cog14, CDR‐SB
BAN2401	Eisai, biogen	NCT03887455	Clarity AD	MCI due to AD or mild AD	22–30	CDR‐SB
BHV4157 (troriluzole)	Biohaven pharma, ADCS	NCT03605667	T2 Protect	Mild to moderate AD	—	ADAS‐Cog11, CDR‐SB
CAD106	Novartis, banner Alzheimer's institute, NIA, Alzheimer's association, amgen	NCT02565511	Generation S1	Preclinical; homozygous ApoE4 genotype	≥24	Time to diagnosis of MCI or dementia due to AD, APCC
COR388	Cortexyme	NCT03823404	GAIN	Mild to moderate AD	12–24	ADAS‐Cog11, CDR‐SB
Gantenerumab	Roche	NCT02051608	Marguerite road	Mild AD	—	ADAS‐Cog13, ADCD‐ADL
		NCT01224106	SCarlet road	Prodromal AD	≥24	CDR‐SB
		NCT03444870	GRADUATE I	Prodromal or mild AD	≥22	CDR‐SB
		NCT03443973	GRADUATE II	Prodromal or mild AD	≥22	CDR‐SB
Gantenerumab and solanezumab	Washington University, Eli Lilly, Roche, NIA, Alzheimer's Association	NCT01760005	DIAN‐TU‐001	Carriers of dominantly inherited AD mutations who are cognitively normal or with MCI or mild dementia	—	DIAN‐TU cognitive composite score
Icosapent ethyl	VA office of research and development, University of Wisconsin, Madison	NCT02719327	BRAVE‐EPA	Cognitively normal with parental history of AD and increased prevalence of ApoE4	—	Brain blood flow using arterial spin‐labeling MRI
Losartan and amlodipine and atorvastatin + exercise	University of Texas Southwestern	NCT02913664	rrAD	Preclinical; family history of dementia or subjective cognitive decline with high blood pressure	≥26	ADCS‐PACC, NIH‐TB Cognition Battery
Mastinib	AB Science	NCT01872598	AB09004	Mild to moderate AD	12–25	ADCS‐ADL, ADAS‐Cog
Metformin	Columbia University, NIA, EMD serono	NCT04098666	MAP	aMCI, overweight or obese	≥24	FCSRT
Solanezumab	Eli Lilly, ATRI	NCT02008357	A4	Preclinical with amyloid evidence	25–30	ADCS‐PACC
Tricaprilin	Cerecin	NCT04187547	AC‐19‐020	Mild to moderate AD who are ApoE4 non‐carriers	14–26	ADAS‐Cog11
TRx0237	TauRx therapeutics	NCT03446001	LUCIDITY	Probable AD or MCI due to AD	16–27	ADAS‐Cog11, ADCS‐ADL

Abbreviations: ADAS‐Cog, Alzheimer's Disease Assessment Scale‐Cognitive Subscale; ADCS‐ADL, Alzheimer's Disease Cooperative Study‐Activities of Daily Living; ADCS‐PACC, Alzheimer's Disease Cooperative Study‐Preclinical Alzheimer Cognitive Composite; APCC, Alzheimer's Prevention Initiative Composite Cognitive; ApoE, apolipoprotein E; ATRI, Alzheimer's Therapeutic Research Institute; CDR‐SB, Clinical Dementia Eating‐Sum of Boxes; FCSRT, Free and Cued Selective Reminding Test; HbA1c, hemoglobin A1c; MCI, mild cognitive impairment; NIA, National Institute on Aging; NIH‐TB, National Institutes of Health toolbox.