Trial Outcomes & Findings for A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT) (NCT NCT04640077)

Last Updated: 2025-06-13

Results Overview

Part A didn't involve any drug and drug related efficacy analyses. Participants in Part A were divided into 2 groups, and they completed the same set of clinical assessments. Participants in Part A Group 1 completed the clinical assessments at a clinic site first (on-site) followed by at home assessments (VTC). Participants in Part A Group 2 completed the assessments at home first, followed by on-site assessment. The goal of Part A was to evaluate the comparability of remote and on-site clinical assessments. The intra-class correlation coefficient (ICC), a measure of agreement for continuous outcome measures, was used to determine agreement between remote and onsite assessments for each outcome measure. Outcome measure tested were the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog13), Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL), Mini Mental State Examination (MMSE), and Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

95 participants

Primary outcome timeframe

Baseline to 4 Weeks

Results posted on

2025-06-13

Participant Flow

Study AACH was an extension of sponsor-approved originating donanemab studies AACC (NCT01837641) and AACG (NCT03367403). This was a two-part study (Parts A and B). Participants received the study drug only in Part B, whereas Part A consisted of clinical assessments.

Participants in Part A were randomized 1:1 into two groups (Group 1 and Group 2) to have their cognitive and functional scales assessed.

Participant milestones

Participant milestones
Measure	Part A - Group 1: Validation of Remote Scale Assessments Participants from the originating trials did not receive any drug in Part A. Participants in Group 1 underwent cognitive/functional scale assessment at the study site (on-site), followed by an at-home assessment (VTC; video teleconference). Total time in Part A - Group 1 was up to 24 weeks.	Part A - Group 2: Validation of Remote Scale Assessments Participants from the originating trials did not receive any drug in Part A. Participants in Group 2 underwent cognitive/functional scale assessment at home (VTC), followed by assessment on-site. Total time in Part A - Group 2 was up to 24 weeks.	Part B: Donanemab Participants who had received placebo in the originating trials received 700 milligrams (mg) donanemab administered intravenously (IV) every 4 weeks (Q4W) for 3 doses, then 1400 mg donanemab administered IV Q4W for up to 48 weeks.
Period 1 STARTED	50	45	0
Period 1 Received At Least 1 Dose of Study Drug	0	0	0
Period 1 COMPLETED	43	39	0
Period 1 NOT COMPLETED	7	6	0
Period 2 STARTED	0	0	55
Period 2 Received At Least 1 Dose of Study Drug	0	0	55
Period 2 COMPLETED	0	0	25
Period 2 NOT COMPLETED	0	0	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A - Group 1: Validation of Remote Scale Assessments Participants from the originating trials did not receive any drug in Part A. Participants in Group 1 underwent cognitive/functional scale assessment at the study site (on-site), followed by an at-home assessment (VTC; video teleconference). Total time in Part A - Group 1 was up to 24 weeks.	Part A - Group 2: Validation of Remote Scale Assessments Participants from the originating trials did not receive any drug in Part A. Participants in Group 2 underwent cognitive/functional scale assessment at home (VTC), followed by assessment on-site. Total time in Part A - Group 2 was up to 24 weeks.	Part B: Donanemab Participants who had received placebo in the originating trials received 700 milligrams (mg) donanemab administered intravenously (IV) every 4 weeks (Q4W) for 3 doses, then 1400 mg donanemab administered IV Q4W for up to 48 weeks.
Period 1 Withdrawal by Subject	4	5	0
Period 1 Adverse Event	1	1	0
Period 1 Screen Failure	2	0	0
Period 2 Withdrawal by Subject	0	0	18
Period 2 Adverse Event	0	0	6
Period 2 Lost to Follow-up	0	0	2
Period 2 Death	0	0	2
Period 2 Progressive Disease	0	0	1
Period 2 Withdrawal Due To Caregiver Circumstances	0	0	1

Baseline Characteristics

A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Validation of Remote Scale Assessments n=95 Participants Participants from the originating trials did not receive any drug in Part A. Participants were randomized 1:1 into two groups to have their cognitive and functional scales assessed. Group 1: Cognitive/functional scale assessment at the study site (on-site), followed by an at-home assessment (VTC; video teleconference), or Group 2: Cognitive/functional scale assessment at home (VTC), followed by assessment on-site. Total time in Part A was up to 24 weeks. After Part A, participants who had received placebo in the originating trials moved to Part B.
Age, Continuous	77.8 years STANDARD_DEVIATION 5.6 • n=93 Participants
Sex: Female, Male Female	52 Participants n=93 Participants
Sex: Female, Male Male	43 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	83 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	9 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	93 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment Canada	9 Participants n=93 Participants
Region of Enrollment United States	86 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline to 4 Weeks

Population: All participants in Part A who had evaluable data for this outcome.

Outcome measures

Outcome measures
Measure	Part A: Validation of Remote Scale Assessments n=84 Participants Participants from the originating trials did not receive any drug in Part A. Participants were randomized 1:1 into two groups to have their cognitive and functional scales assessed. * Group 1: Cognitive/functional scale assessment at the study site (on-site), followed by an at-home assessment (VTC; video teleconference), or * Group 2: Cognitive/functional scale assessment at home (VTC), followed by assessment on-site.
Part A: Intraclass Correlation Between On-Site and Video Teleconference (VTC) Assessments ADCS-ADL	0.8819 Intraclass correlation coefficient Interval 0.8227 to 0.9222
Part A: Intraclass Correlation Between On-Site and Video Teleconference (VTC) Assessments CDR-SB	0.8254 Intraclass correlation coefficient Interval 0.738 to 0.8852
Part A: Intraclass Correlation Between On-Site and Video Teleconference (VTC) Assessments ADAS-Cog13	0.8172 Intraclass correlation coefficient Interval 0.7293 to 0.8785
Part A: Intraclass Correlation Between On-Site and Video Teleconference (VTC) Assessments MMSE	0.8251 Intraclass correlation coefficient Interval 0.7148 to 0.8907

PRIMARY outcome

Timeframe: Baseline Up To 96 Weeks

Population: All participants from Part B, who received at least one dose of donanemab.

Percentage of participants with TEAEs and SAEs were reported here. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.

Outcome measures

Outcome measures
Measure	Part A: Validation of Remote Scale Assessments n=55 Participants Participants from the originating trials did not receive any drug in Part A. Participants were randomized 1:1 into two groups to have their cognitive and functional scales assessed. * Group 1: Cognitive/functional scale assessment at the study site (on-site), followed by an at-home assessment (VTC; video teleconference), or * Group 2: Cognitive/functional scale assessment at home (VTC), followed by assessment on-site.
Part B: Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs	90.9 Percentage of participants
Part B: Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	29.1 Percentage of participants

PRIMARY outcome

Timeframe: Baseline, Week 72

Population: All participants in Part B, who received at least one dose of donanemab and had evaluable data for this outcome.

Number of Participants with Suicidality Based on C-SSRS was reported.

Outcome measures

Outcome measures
Measure	Part A: Validation of Remote Scale Assessments n=53 Participants Participants from the originating trials did not receive any drug in Part A. Participants were randomized 1:1 into two groups to have their cognitive and functional scales assessed. * Group 1: Cognitive/functional scale assessment at the study site (on-site), followed by an at-home assessment (VTC; video teleconference), or * Group 2: Cognitive/functional scale assessment at home (VTC), followed by assessment on-site.
Part B: Number of Participants With Suicidality Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Behavior	1 Participants
Part B: Number of Participants With Suicidality Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation	3 Participants

SECONDARY outcome

Timeframe: Baseline, Week 72

Population: All participants in Part B who received at least one dose of donanemab and had evaluable data for this outcome.

The MMSE is an instrument used to assess cognitive function in participants. The instrument measures orientation, memory, and attention; the ability of the participant to name objects; follow verbal and written commands; write a sentence; and copy figures. The range for the total MMSE score is 0 to 30, with lower scores indicating greater level of impairment. LS Mean was determined by Mixed Models for Repeated Measurements (MMRM) model with Baseline + Visit + Baseline\*Visit + Age + Years of Education + Presence/ Absence of Anti-dementia Drugs as variables.

Outcome measures

Outcome measures
Measure	Part A: Validation of Remote Scale Assessments n=55 Participants Participants from the originating trials did not receive any drug in Part A. Participants were randomized 1:1 into two groups to have their cognitive and functional scales assessed. * Group 1: Cognitive/functional scale assessment at the study site (on-site), followed by an at-home assessment (VTC; video teleconference), or * Group 2: Cognitive/functional scale assessment at home (VTC), followed by assessment on-site.
Part B: Change From Baseline on the Mini Mental State Examination (MMSE) Score	-0.87 Score on a scale Standard Error 0.557

SECONDARY outcome

Timeframe: Baseline, Week 72

Population: All participants in Part B, who received at least one dose of donanemab and had evaluable data for this outcome.

The ADAS-Cog13 (13-item version of ADAS Cog) assesses areas of cognitive function that are the most typically impaired in Alzheimer's Disease (AD): orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze-completion measures. The ADAS-Cog13 scale ranges from 0 to 85, with higher scores indicating greater disease severity. LS Mean was determined by MMRM model with Baseline + Visit + Baseline\*Visit + Age + Years of Education + Presence/Absence of Anti-dementia Drugs as variables.

Outcome measures

Outcome measures
Measure	Part A: Validation of Remote Scale Assessments n=55 Participants Participants from the originating trials did not receive any drug in Part A. Participants were randomized 1:1 into two groups to have their cognitive and functional scales assessed. * Group 1: Cognitive/functional scale assessment at the study site (on-site), followed by an at-home assessment (VTC; video teleconference), or * Group 2: Cognitive/functional scale assessment at home (VTC), followed by assessment on-site.
Part B: Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score	4.63 Score on a scale Standard Error 1.195

SECONDARY outcome

Timeframe: Baseline, Week 72

Population: All participants in Part B, who received at least one dose of donanemab and had evaluable data for this outcome.

The iADRS is a composite that measures both cognition and function from the ADAS-Cog and the ADCS-iADL (Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living). The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 (score range 0 to 85 with higher scores reflecting worse performance) and the ADCS-iADL (score range from 0-59 with higher scores reflecting better performance). The iADRS score ranges from 0 to 144 with lower scores indicating greater impairment. LS Mean was determined by MMRM model using Baseline + Visit + Baseline\*Visit + Age + Years of Education + Presence/Absence of Anti-dementia Drugs as variables.

Outcome measures

Outcome measures
Measure	Part A: Validation of Remote Scale Assessments n=55 Participants Participants from the originating trials did not receive any drug in Part A. Participants were randomized 1:1 into two groups to have their cognitive and functional scales assessed. * Group 1: Cognitive/functional scale assessment at the study site (on-site), followed by an at-home assessment (VTC; video teleconference), or * Group 2: Cognitive/functional scale assessment at home (VTC), followed by assessment on-site.
Part B: Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)	-10.14 Score on a scale Standard Error 1.850

SECONDARY outcome

Timeframe: Baseline, Week 72

Population: All participants in Part B, who received at least one dose of donanemab and had evaluable data for this outcome.

The ADCS-iADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean was determined by MMRM model using = Baseline + Visit + Baseline\*Visit + Age + Years of Education + Presence/Absence of Anti-dementia Drugs as variables.

Outcome measures

Outcome measures
Measure	Part A: Validation of Remote Scale Assessments n=55 Participants Participants from the originating trials did not receive any drug in Part A. Participants were randomized 1:1 into two groups to have their cognitive and functional scales assessed. * Group 1: Cognitive/functional scale assessment at the study site (on-site), followed by an at-home assessment (VTC; video teleconference), or * Group 2: Cognitive/functional scale assessment at home (VTC), followed by assessment on-site.
Part B: Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL)	-6.21 Score on a scale Standard Error 1.149

SECONDARY outcome

Timeframe: Baseline, Week 72

Population: All participants in Part B who received at least one dose of donanemab and had evaluable data for this outcome.

The CDR-SB is a global assessment tool than can be used to effectively evaluate both cognition and function. Participant's cognitive status is rated across 6 domains or 'boxes' of functioning: Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care. The CDR-SB scores are calculated by adding the box scores and range from 0 to 18 with higher scores indicative of more impairment. LS Mean was determined by MMRM model using Baseline + Visit + Baseline\*Visit + Age + Years of Education + Presence/Absence of Anti-dementia Drugs as variables.

Outcome measures

Outcome measures
Measure	Part A: Validation of Remote Scale Assessments n=55 Participants Participants from the originating trials did not receive any drug in Part A. Participants were randomized 1:1 into two groups to have their cognitive and functional scales assessed. * Group 1: Cognitive/functional scale assessment at the study site (on-site), followed by an at-home assessment (VTC; video teleconference), or * Group 2: Cognitive/functional scale assessment at home (VTC), followed by assessment on-site.
Part B: Change From Baseline on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)	1.87 Score on a scale Standard Error 0.364

SECONDARY outcome

Timeframe: Baseline, Week 36

Population: All participants in Part B, who received at least one dose of donanemab and had evaluable data for this outcome.

Florbetapir PET imaging was used as a quantitative amyloid biomarker. Florbetapir PET scans at baseline and at 36 weeks after the first treatment were used to quantitatively estimate change in amyloid plaques. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. LS Mean was determined by ANCOVA model using originating study's Baseline + Age + Treatment (Type III sum of squares) as variables.

Outcome measures

Outcome measures
Measure	Part A: Validation of Remote Scale Assessments n=36 Participants Participants from the originating trials did not receive any drug in Part A. Participants were randomized 1:1 into two groups to have their cognitive and functional scales assessed. * Group 1: Cognitive/functional scale assessment at the study site (on-site), followed by an at-home assessment (VTC; video teleconference), or * Group 2: Cognitive/functional scale assessment at home (VTC), followed by assessment on-site.
Part B: Change From Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 Positron Emission Tomography (PET) Scan	-80.1 Centiloids Standard Error 4.40

SECONDARY outcome

Timeframe: Baseline, Week 72

Population: All participants in Part B who received at least one dose of donanemab and had evaluable data for this outcome.

Change from Baseline in Whole Brain Volume as Measured by vMRI in Part B. LS mean were derived using MMRM model with fixed factors for visit, and covariates for baseline score, and age at baseline.

Outcome measures

Outcome measures
Measure	Part A: Validation of Remote Scale Assessments n=55 Participants Participants from the originating trials did not receive any drug in Part A. Participants were randomized 1:1 into two groups to have their cognitive and functional scales assessed. * Group 1: Cognitive/functional scale assessment at the study site (on-site), followed by an at-home assessment (VTC; video teleconference), or * Group 2: Cognitive/functional scale assessment at home (VTC), followed by assessment on-site.
Part B: Change From Baseline in Whole Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)	-27.75 cubic centimeters (cm3) Standard Error 2.060

SECONDARY outcome

Timeframe: Predose at Week 8 and Week 16

Population: All participants in Part B, who received at least one dose of donanemab and had evaluable PK data.

PK: Trough Concentration of donanemab. Ctrough is the concentration of drug in the blood immediately before the next dose of drug was administered.

Outcome measures

Outcome measures
Measure	Part A: Validation of Remote Scale Assessments n=53 Participants Participants from the originating trials did not receive any drug in Part A. Participants were randomized 1:1 into two groups to have their cognitive and functional scales assessed. * Group 1: Cognitive/functional scale assessment at the study site (on-site), followed by an at-home assessment (VTC; video teleconference), or * Group 2: Cognitive/functional scale assessment at home (VTC), followed by assessment on-site.
Part B: Pharmacokinetics (PK): Trough Concentrations of Donanemab (Ctrough) Ctrough at Week 8	5.62 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 165
Part B: Pharmacokinetics (PK): Trough Concentrations of Donanemab (Ctrough) Ctrough at Week 16	6.64 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 581

SECONDARY outcome

Timeframe: Baseline, 4, 8, 16, 24, 36, 48, 60, 72, 84, and 96 Weeks

Population: All participants in Part B who received at least one dose of donanemab and had baseline and at least one post baseline ADA assessment.

Number of participants in Part B with positive Anti-drug antibodies (TE ADA+) was reported. A TE ADA evaluable participant is classified as TE ADA+ if they have at least one postbaseline titer that is 4 times or more higher than the baseline titer (treatment-boosted). If the baseline result is ADA Not Present, the subject is considered TE ADA+ if there is at least one postbaseline result showing ADA present with a titer of 1:10 or higher (treatment-induced).

Outcome measures

Outcome measures
Measure	Part A: Validation of Remote Scale Assessments n=47 Participants Participants from the originating trials did not receive any drug in Part A. Participants were randomized 1:1 into two groups to have their cognitive and functional scales assessed. * Group 1: Cognitive/functional scale assessment at the study site (on-site), followed by an at-home assessment (VTC; video teleconference), or * Group 2: Cognitive/functional scale assessment at home (VTC), followed by assessment on-site.
Part B: Number or Participants With Treatment-Emergent Anti-Drug Antibodies (TE ADA) of Donanemab	38 Participants

Adverse Events

Period 1: Part A - Group 1: Validation of Remote Scale Assessments

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Period 1: Part A - Group 2: Validation of Remote Scale Assessments

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Period 2: Part B: Donanemab

Serious events: 16 serious events

Other events: 40 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Period 1: Part A - Group 1: Validation of Remote Scale Assessments n=50 participants at risk Participants from the originating trials did not receive any drug in Part A. Participants in Group 1 underwent cognitive/functional scale assessment at the study site (on-site), followed by an at-home assessment (VTC; video teleconference).	Period 1: Part A - Group 2: Validation of Remote Scale Assessments n=45 participants at risk Participants from the originating trials did not receive any drug in Part A. Participants in Group 2 underwent cognitive/functional scale assessment at home (VTC), followed by assessment on-site.	Period 2: Part B: Donanemab n=55 participants at risk Participants who had received placebo in the originating trials received 700 mg donanemab administered IV Q4W for 3 doses, then 1400 mg donanemab administered IV Q4W for up to 48 weeks.
General disorders Asthenia	0.00% 0/50 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	0.00% 0/45 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	5.5% 3/55 • Number of events 3 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.
Infections and infestations Covid-19	0.00% 0/50 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	0.00% 0/45 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	12.7% 7/55 • Number of events 7 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.
Infections and infestations Urinary tract infection	0.00% 0/50 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	0.00% 0/45 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	10.9% 6/55 • Number of events 16 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.
Injury, poisoning and procedural complications Fall	0.00% 0/50 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	0.00% 0/45 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	12.7% 7/55 • Number of events 10 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/50 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	0.00% 0/45 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	14.5% 8/55 • Number of events 15 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.
Investigations Blood pressure increased	0.00% 0/50 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	0.00% 0/45 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	5.5% 3/55 • Number of events 3 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/50 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	0.00% 0/45 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	5.5% 3/55 • Number of events 3 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.
Nervous system disorders Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits	0.00% 0/50 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	0.00% 0/45 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	18.2% 10/55 • Number of events 10 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.
Nervous system disorders Amyloid related imaging abnormality-oedema/effusion	0.00% 0/50 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	0.00% 0/45 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	27.3% 15/55 • Number of events 16 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.
Nervous system disorders Cerebral microhaemorrhage	0.00% 0/50 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	0.00% 0/45 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	5.5% 3/55 • Number of events 3 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.
Nervous system disorders Headache	0.00% 0/50 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	0.00% 0/45 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	7.3% 4/55 • Number of events 4 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.
Nervous system disorders Superficial siderosis of central nervous system	0.00% 0/50 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	0.00% 0/45 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	5.5% 3/55 • Number of events 6 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.
Psychiatric disorders Anxiety	0.00% 0/50 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	0.00% 0/45 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	5.5% 3/55 • Number of events 3 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.
Psychiatric disorders Confusional state	0.00% 0/50 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	0.00% 0/45 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.	5.5% 3/55 • Number of events 3 • Baseline Up To 96 Weeks All enrolled participants. Participants in Part A did not receive any intervention (i.e., study drug). As such, there were no treatment emergent adverse events in Part A. Per pre-planned analysis, adverse events for Part A were reported as per the groups they were randomized into (Group 1 and Group 2) and not as per VTC or on-site as every participant was supposed to participate in both VTC and on-site assessments.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60