Table 1.

Baseline characteristics and overview of the included trials.

Sr. No.	Author	Year	Title	Journal	Phase	Design	Inclusion Criteria	Pharmacologic Intervention	Outcome Measures	Follow-up
1	Lowe (1)	2021	Donanemab (LY3002813) dose-escalation study in Alzheimer’s disease	Translational Research & Clinical Interventions	Phase 1 study	Subject- and investigator-blind, randomized, placebo-controlled, parallel-group, a seven-arm study of single-dose, followed by a multiple-dose, dose-escalation study	Men or non-fertile women ≥50 years of age with evidence of memory impairment on FCSRT-IR picture version, MMSE score of 16 to 30, and a florbetapir PET scan consistent with amyloid pathology	Arm 1: 0.1 mg/kg IV (intervention: four patients, placebo: two patients); Arm 2: 0.3 mg/kg IV (intervention: seven patients, placebo: two patients) Arm 3: 1 mg/kg IV (intervention: nine patients, placebo: two patients) Arm 4: 3 mg/kg IV (intervention: 11 patients, placebo: 3 patients) Arm 5: 10 mg/kg IV (intervention: six patients, placebo: three patients) Arm 6: 3 mg/kg SC (intervention: eight patients) Arm 7: 1 mg/kg IV in six healthy volunteers	Brain amyloid plaque levels with Florbetapir-PET with SUVR; ADAS-Cog-14; MMSE; FCSRT-IR	48-week period
2	Lowe	2021	Donanemab (LY3002813) Phase 1b Study in Alzheimer’s Disease: Rapid and Sustained Reduction of Brain Amyloid Measured by Florbetapir F18 Imaging	The Journal of Prevention of Alzheimer’s Disease	Phase 1b	Three-part, patient- and investigator-blind, randomized within cohort, placebo-controlled, parallel-group, six-arm, single and multiple-dose study	Men or non-fertile women ≥50 years with evidence of memory impairment on FCSRT-IR, picture version, MMSE score of 16–30, CDR of 0.5–2, memory box score ≥0.5, and a florbetapir PET scan consistent with amyloid pathology	Cohorts 1–3 (single, IC dose of Donanemab 10 mg/kg, 20 mg/kg, 40 mg/kg) or placebo; Cohort 4 (multiple IV doses of Donanemab 10 mg/kg) or placebo every 2 weeks for 24 weeks; Cohorts 5–6 (multiple IV doses of Donanemab, 10 mg/kg, 20 mg/kg) or placebo every 4 weeks for 72 weeks	Brain amyloid plaque levels with 18F-flortaucipir PET scan with SUVR values; CDR; MMSE; FCSRT-IR; ADAS-Cog-14; ADCS-MCI-ADL-24; NTB	72 weeks (Cohorts 1 and 2); 24 weeks (Cohort 3); 48 weeks (Cohort 4); 12 weeks (Cohorts 5–6)
3	Mintun	2021	Donanemab in Early Alzheimer’s Disease	The New England Journal of Medicine	Phase 2 trial (NCT03367403)	Multicenter, randomized, double-blind, placebo-controlled trial	Patients 60 to 85 years of age who had early symptomatic AD, defined as prodromal AD or mild AD with dementia, and had an MMSE score of 20 to 28; flortaucipir PET scans with evidence of pathologic tau deposition but with quantitative tau levels between 1.10 and 1.46 except in advanced AD where tau levels ≤1.10 included with elevated amyloid levels (equivalent to ≥37 CL)	1:1 ratio to receive either Donanemab (700 mg for the first three doses and 1400 mg thereafter) or placebo, administered intravenously every 4 weeks for up to 72 weeks	Change from baseline to 76 weeks in iADRS score *; Change from baseline in CDR-SB scores; ADAS-Cog13, the ADCS-iADL, and the MMSE	76 weeks
4	Shcherbinin	2022	Association of Amyloid Reduction After Donanemab Treatment With Tau Pathology and Clinical Outcomes: The TRAILBLAZER-ALZ Randomized Clinical Trial	JAMA Neurology	Phase 2 (NCT03367403)	Multicenter, double-blind, phase 2, placebo-controlled, randomized clinical trial	Participants with AD who had an intermediate tau level (moderate AD patterns based on visual assessment and SUVR between 1.10 and 1.46, inclusive, or advanced AD patterns and SUVR ≤1.10) plus elevated amyloid level (equivalent to ≥37 CL)	Donanemab dosing was given every 4 weeks: 700 mg for the first 3 doses, then 1400 mg for up to 72 weeks.	Change from baseline in the score on the iADRS; Change in amyloid, tau, and clinical decline after Donanemab intervention	48-week period

* Integrated Alzheimer’s Disease Rating Scale (iADRS; range, 0 to 144, with lower scores indicating greater cognitive and functional impairment). Acronyms: AD: Alzheimer’s disease; ADAS-Cog₁₃: the 13-item cognitive subscale of the Alzheimer’s Disease Assessment Scale; ADAS-Cog₁₄: the 14-item cognitive subscale of the Alzheimer’s Disease Assessment Scale; ADCS-iADL: the Alzheimer’s Disease Cooperative Study–Instrumental Activities of Daily Living Inventory; ADCS-MCI-ADL-24: Alzheimer’s Disease Cooperative Study–Activities of Daily Living–Mild Cognitive Impairment 24-item version; CDR-SB: Clinical Dementia Rating Scale–Sum of Boxes; CL: Centiloids; FCSRT-IR: Free and Cued Selective Reminding Test Immediate Recall; MMSE: Mini-Mental State Examination; NTB: Neuropsychological Test Battery; PET: Positron emission tomography; SUVR: Standardized uptake value ratio.