ACTIVE, NOT RECRUITING - HAS RESULTS
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Sponsor
Eli Lilly and Company
Information Provided by (Responsible Party)
Eli Lilly and Company
Clinicaltrials.gov Identifier
NCT04437511 Other Study ID Numbers: 17737 First Submitted: June 17, 2020 First Posted: June 18, 2020 Results First Posted: May 20, 2024 Last Update Posted: September 23, 2024 Last Verified: September 2024 History of Changes
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Received at Least One Dose of Drug (Safety Population)
853
874
COMPLETED
622
698
NOT COMPLETED
238
178
Adverse Event
50
21
Death
15
10
Lost to Follow-up
11
11
Physician Decision
19
10
Progressive Disease
4
7
Withdrawal by Subject
111
94
Withdrawal due to Caregiver Circumstances
21
20
Continuing Study
7
5
Baseline Characteristics
Arm/Group Title
Donanemab
Placebo
Total
Overall Number of Baseline Participants
860
876
1736
Age, Continuous | Measure Type: Mean | Unit of measure: years
Number Analyzed
860 years
876 years
1736 years
72.98 (8.5%)
73.04 (8.3%)
73.01 (4.2%)
Sex/Gender, Customized | Measure Type: Number | Unit of measure: participants
Number Analyzed
853 participants
874 participants
1727 participants
488 (56.7%)
501 (57.2%)
989 (57%)
Measure Analysis Population Description: Safety Population: All randomized participants who received at least one dose of study drug.
Sex: Female, Male | Measure Type: Count of Participants | Unit of measure: Participants
Number Analyzed
860 participants
876 participants
1736 participants
Female
493 (57.3%)
503 (57.4%)
996 (57.4%)
Male
367 (42.7%)
373 (42.6%)
740 (42.6%)
Ethnicity (NIH/OMB) | Measure Type: Count of Participants | Unit of measure: Participants
Number Analyzed
860 participants
876 participants
1736 participants
Hispanic or Latino
35 (4.1%)
36 (4.1%)
71 (4.1%)
Not Hispanic or Latino
583 (67.8%)
594 (67.8%)
1177 (67.8%)
Unknown or Not Reported
242 (28.1%)
246 (28.1%)
488 (28.1%)
Race (NIH/OMB) | Measure Type: Count of Participants | Unit of measure: Participants
Number Analyzed
860 participants
876 participants
1736 participants
American Indian or Alaska Native
2 (0.2%)
2 (0.1%)
Asian
57 (6.6%)
47 (5.4%)
104 (6%)
Native Hawaiian or Other Pacific Islander
Black or African American
19 (2.2%)
21 (2.4%)
40 (2.3%)
White
781 (90.8%)
807 (92.1%)
1588 (91.5%)
More than one race
1 (0.1%)
1 (0.1%)
Unknown or Not Reported
1 (0.1%)
1 (0.1%)
Region of Enrollment | Measure Type: Count of Participants | Unit of measure: Participants
Number Analyzed
860 participants
876 participants
1736 participants
13 (1.5%)
4 (0.5%)
17 (1%)
Integrated Alzheimer's Disease Rating Scale (iADRS) | Measure Type: Mean | Unit of measure: Score on a scale
Number Analyzed
860 score on a scale
876 score on a scale
1736 score on a scale
104.10 (12.1%)
103.56 (11.8%)
103.83 (6%)
Screening Tau Category | Measure Type: Count of Participants | Unit of measure: Participants
Number Analyzed
859 participants
875 participants
1734 participants
588 (68.4%)
594 (67.8%)
1182 (68.1%)
Measure Analysis Population Description: All randomized participants (pts) who have only evaluable Screening Tau category data.Intermediate tau (Low-medium):All pts with baseline composite tau PET standardized uptake value ratio (SUVr) <= 1.46 and a topographic deposition pattern consistent with advanced AD (AD++) or 1.10 <= SUVr <= 1.46 and a topographic deposition pattern consistent with moderate AD (AD+).High tau:All pts with SUVr >1.46 and topographic deposition pattern consistent with either moderate (AD+) or advanced AD (AD++).
Outcome Measures
Primary Outcome
Title
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population)
Description
Integrated Alzheimer's Disease Rating Scale is used to assess whether donanemab slows down the clinical decline associated with AD compared with placebo. iADRS is an integrated assessment of cognition and daily function comprised of items from the ADAS-Cog13 and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). The scale ranges from 0 to 144, where lower scores indicate worse performance and higher score indicates better performance. Least Squares (LS) Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, baseline tau level, and baseline acetylcholinesterase inhibitor (AchI)/Memantine use.
Time Frame
Baseline, Week 76
Analysis Population Description
All randomized participants with a baseline and at least one postbaseline iADRS data point.
Arm/Group Title
Donanemab
Placebo
Overall Number of Participants Analyzed
775
824
Least Squares Mean (Standard Error) | Unit of Measure: score on a scale
-10.19 (0.53)
-13.11 (0.50)
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
Donanemab, Placebo
Type of Statistical Test
Superiority
Statistical Test of Hypothesis
P-Value
<0.001
Method
Mixed Models Analysis
Method of Estimation
Estimation Parameter
LS Mean change difference (Final Values)
Estimated Value
2.92
Estimation Comments
2-Sided
Primary Outcome
Title
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population)
Description
Integrated Alzheimer's Disease Rating Scale is used to assess whether donanemab slows down the clinical decline associated with AD compared with placebo. iADRS is an integrated assessment of cognition and daily function comprised of items from the Alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog13) and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). The scale ranges from 0 to 144, where lower scores indicate worse performance and higher score indicates better performance. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, and baseline AchI/Memantine use.
Time Frame
Baseline, Week 76
Analysis Population Description
All randomized participants with baseline Intermediate Tau level and with baseline and at least one postbaseline iADRS data point.
Arm/Group Title
Donanemab
Placebo
Overall Number of Participants Analyzed
533
560
Least Squares Mean (Standard Error) | Unit of Measure: score on a scale
-6.02 (0.50)
-9.27 (0.49)
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
Donanemab, Placebo
Type of Statistical Test
Superiority
Statistical Test of Hypothesis
P-Value
<0.001
Method
Mixed Models Analysis
Method of Estimation
Estimation Parameter
LS Mean change difference (Final Values)
Estimated Value
3.25
Estimation Comments
2-Sided
Secondary Outcome
Title
Change From Baseline on the Mini Mental State Examination (MMSE) Score (Overall Population)
Description
MMSE is an instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures). Total score ranges from 0 to 30; lower score indicates greater disease severity. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, baseline tau level, and baseline AchI/Memantine use.
Time Frame
Baseline, Week 76
Analysis Population Description
All randomized participants with a baseline and at least one postbaseline MMSE data point.
Arm/Group Title
Donanemab
Placebo
Overall Number of Participants Analyzed
796
841
Least Squares Mean (Standard Error) | Unit of Measure: score on a scale
-2.47 (0.14)
-2.94 (0.13)
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
Donanemab, Placebo
Type of Statistical Test
Superiority
Statistical Test of Hypothesis
P-Value
0.012
Method
Mixed Models Analysis
Method of Estimation
Estimation Parameter
LS Mean change difference (Final Values)
Estimated Value
0.47
Estimation Comments
2-Sided
Secondary Outcome
Title
Change From Baseline on the Mini Mental State Examination (MMSE) Score (Intermediate (Low-medium) Tau Population)
Description
MMSE is an instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures). Total score ranges from 0 to 30; lower score indicates greater disease severity. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, and baseline AchI/Memantine use.
Time Frame
Baseline, Week 76
Analysis Population Description
All randomized participants with baseline Intermediate Tau level and with baseline and at least one postbaseline MMSE data point.
Arm/Group Title
Donanemab
Placebo
Overall Number of Participants Analyzed
549
573
Least Squares Mean (Standard Error) | Unit of Measure: score on a scale
-1.61 (0.14)
-2.09 (0.14)
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
Donanemab, Placebo
Type of Statistical Test
Superiority
Statistical Test of Hypothesis
P-Value
0.016
Method
Mixed Models Analysis
Method of Estimation
Estimation Parameter
LS Mean change difference (Final Values)
Estimated Value
0.48
Estimation Comments
2-Sided
Secondary Outcome
Title
Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Overall Population)
Description
The ADAS-Cog13 is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS-Cog13 consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, baseline tau level, and baseline AchI/Memantine use.
Time Frame
Baseline, Week 76
Analysis Population Description
All randomized participants with a baseline and at least one postbaseline ADAS-Cog13 data point.
Arm/Group Title
Donanemab
Placebo
Overall Number of Participants Analyzed
797
841
Least Squares Mean (Standard Error) | Unit of Measure: score on a scale
5.46 (0.28)
6.79 (0.27)
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
Donanemab, Placebo
Type of Statistical Test
Superiority
Statistical Test of Hypothesis
P-Value
0.0006
Method
Mixed Models Analysis
Method of Estimation
Estimation Parameter
LS Mean change difference (Final Values)
Estimated Value
-1.33
Estimation Comments
2-Sided
Secondary Outcome
Title
Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Intermediate (Low-medium) Tau Population)
Description
The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS-cog consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, and baseline AchI/Memantine use.
Time Frame
Baseline, Week 76
Analysis Population Description
All randomized participants with baseline Intermediate Tau level and with baseline and at least one postbaseline ADAS-Cog13 data point.
Arm/Group Title
Donanemab
Placebo
Overall Number of Participants Analyzed
550
570
Least Squares Mean (Standard Error) | Unit of Measure: score on a scale
3.17 (0.27)
4.69 (0.26)
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
Donanemab, Placebo
Type of Statistical Test
Superiority
Statistical Test of Hypothesis
P-Value
<0.001
Method
Mixed Models Analysis
Method of Estimation
Estimation Parameter
LS Mean change difference (Final Values)
Estimated Value
-1.52
Estimation Comments
2-Sided
Secondary Outcome
Title
Change From Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (Overall Population)
Description
CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean value was adjusted for treatment, visit, treatment-by-visit interaction, and covariates for baseline score, baseline score-by-visit interaction, age at baseline, baseline tau category, pooled investigator, and baseline AchI/Memantine use.
Time Frame
Baseline, Week 76
Analysis Population Description
All randomized participants with a baseline and at least one postbaseline CDR-SB data point.
Arm/Group Title
Donanemab
Placebo
Overall Number of Participants Analyzed
794
838
Least Squares Mean (Standard Error) | Unit of Measure: score on a scale
1.72 (0.096)
2.42 (0.092)
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
Donanemab, Placebo
Type of Statistical Test
Superiority
Statistical Test of Hypothesis
P-Value
<0.001
Method
Mixed Models Analysis
Method of Estimation
Estimation Parameter
LS Mean change difference (Final Values)
Estimated Value
-0.70
Estimation Comments
2-Sided
Secondary Outcome
Title
Change From Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (Intermediate (Low-medium) Tau Population)
Description
CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean value was adjusted for treatment, visit, treatment-by-visit interaction, and covariates for baseline score, baseline score-by-visit interaction, age at baseline, pooled investigator, and baseline AchI/Memantine use.
Time Frame
Baseline, Week 76
Analysis Population Description
All randomized participants with baseline Intermediate Tau level and with baseline and at least one postbaseline CDR-SB data point.
Arm/Group Title
Donanemab
Placebo
Overall Number of Participants Analyzed
546
569
Least Squares Mean (Standard Error) | Unit of Measure: score on a scale
1.20 (0.105)
1.88 (0.102)
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
Donanemab, Placebo
Type of Statistical Test
Superiority
Statistical Test of Hypothesis
P-Value
<0.001
Method
Mixed Models Analysis
Method of Estimation
Estimation Parameter
LS Mean change difference (Final Values)
Estimated Value
-0.67
Estimation Comments
2-Sided
Secondary Outcome
Title
Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) Score (Overall Population)
Description
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities (instrumental activity items 6a, 7-23) of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, baseline tau level, and baseline AchI/Memantine use.
Time Frame
Baseline, Week 76
Analysis Population Description
All randomized participants with a baseline and at least one postbaseline ADCS-iADL data point.
Arm/Group Title
Donanemab
Placebo
Overall Number of Participants Analyzed
780
826
Least Squares Mean (Standard Error) | Unit of Measure: score on a scale
-4.42 (0.32)
-6.13 (0.30)
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
Donanemab, Placebo
Type of Statistical Test
Superiority
Statistical Test of Hypothesis
P-Value
0.0001
Method
Mixed Models Analysis
Method of Estimation
Estimation Parameter
LS Mean change difference (Final Values)
Estimated Value
1.70
Estimation Comments
2-Sided
Secondary Outcome
Title
Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) Score (Intermediate (Low-medium) Tau Population)
Description
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities (instrumental activity items 6a, 7-23) of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, and baseline AchI/Memantine use.
Time Frame
Baseline, Week 76
Analysis Population Description
All randomized participants with a baseline Intermediate Tau level and with baseline and at least one postbaseline ADCS-iADL data point.
Arm/Group Title
Donanemab
Placebo
Overall Number of Participants Analyzed
535
562
Least Squares Mean (Standard Error) | Unit of Measure: score on a scale
-2.76 (0.34)
-4.59 (0.32)
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
Donanemab, Placebo
Type of Statistical Test
Superiority
Statistical Test of Hypothesis
P-Value
<0.001
Method
Mixed Models Analysis
Method of Estimation
Estimation Parameter
LS Mean change difference (Final Values)
Estimated Value
1.83
Estimation Comments
2-Sided
Secondary Outcome
Title
Change From Baseline in Brain Amyloid Plaque Deposition as Measured by Amyloid Positron Emission Tomography (PET) Scan
Description
Amyloid PET scans at baseline and at 76 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 brain regions 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 value was adjusted for treatment, visit, treatment-by-visit interaction, and covariates for baseline score, baseline score-by-visit interaction, baseline tau category, and age at baseline.
Time Frame
Baseline, Week 76
Analysis Population Description
All randomized participants with a baseline and at least one postbaseline amyloid PET scan data point.
Arm/Group Title
Donanemab
Placebo
Overall Number of Participants Analyzed
765
812
Least Squares Mean (Standard Error) | Unit of Measure: centiloids
-87.03 (0.950)
-0.67 (0.909)
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
Donanemab, Placebo
Type of Statistical Test
Superiority
Statistical Test of Hypothesis
P-Value
<0.0001
Method
Mixed Models Analysis
Method of Estimation
Estimation Parameter
LS Mean change difference (Final Values)
Estimated Value
-86.37
Estimation Comments
2-Sided
Secondary Outcome
Title
Change From Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET Scan
Description
Flortaucipir PET imaging was used as a quantitative tau biomarker. Tau PET scans at baseline and at 76 weeks after the first treatment were used to quantitatively estimate change in aggregated tau neurofibrillary tangles (NFTs). Quantitative tau burden was formalized using Standardized Uptake Value Ratio (SUVR) in frontal lobe relative to the cerebellum gray as a reference region. Larger SUVR reflects larger tau burden in the frontal lobe relative to cerebellum gray. LS Mean value was adjusted for baseline score, screening tau category, age and treatment (Type III sum of squares).
Time Frame
Baseline, Week 76
Analysis Population Description
All randomized participants with a baseline and post-baseline tau PET scan.
Arm/Group Title
Donanemab
Placebo
Overall Number of Participants Analyzed
578
654
Least Squares Mean (Standard Error) | Unit of Measure: standardized uptake value ratio (SUVR)
0.0401 (0.00398)
0.0442 (0.00374)
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
Donanemab, Placebo
Type of Statistical Test
Superiority
Statistical Test of Hypothesis
P-Value
0.4522
Method
ANCOVA
Method of Estimation
Estimation Parameter
LS Mean change difference (Final Values)
Estimated Value
-0.0041
Estimation Comments
2-Sided
Secondary Outcome
Title
Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)
Description
MRI scans at baseline and at 76 weeks after the first treatment were used to quantitatively estimate change in brain volume. Volumetric MRI parameters were measured in bilateral hippocampus, bilateral whole brain, and bilateral ventricles. LS Mean value was adjusted for treatment, visit, treatment-by-visit interaction, and covariates for baseline score, baseline tau category, and age at baseline.
Time Frame
Baseline, Week 76
Analysis Population Description
All randomized participants with a baseline and at least one postbaseline vMRI data point.
Arm/Group Title
Donanemab
Placebo
Overall Number of Participants Analyzed
786
831
Least Squares Mean (Standard Error) | Unit of Measure: cubic centimeter (cm^3)
Bilateral Hippocampus
-0.20 (0.005)
-0.22 (0.005)
Bilateral Whole Brain
-27.46 (0.409)
-20.79 (0.392)
Bilateral Ventricles
10.07 (0.185)
7.05 (0.178)
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
Donanemab, Placebo
Comments
Bilateral Hippocampus
Type of Statistical Test
Superiority
Statistical Test of Hypothesis
P-Value
0.002
Method
Mixed Models Analysis
Method of Estimation
Estimation Parameter
LS Mean change difference (Final Values)
Estimated Value
0.02
Estimation Comments
2-Sided
Statistical Analysis 2
Statistical Analysis Overview
Comparison Group Selection
Donanemab, Placebo
Comments
Bilateral Whole Brain
Type of Statistical Test
Superiority
Statistical Test of Hypothesis
P-Value
<0.001
Method
Mixed Models Analysis
Method of Estimation
Estimation Parameter
LS Mean change difference (Final Values)
Estimated Value
-6.66
Estimation Comments
2-Sided
Statistical Analysis 3
Statistical Analysis Overview
Comparison Group Selection
Donanemab, Placebo
Comments
Bilateral Ventricles
Type of Statistical Test
Superiority
Statistical Test of Hypothesis
P-Value
<0.001
Method
Mixed Models Analysis
Method of Estimation
Estimation Parameter
LS Mean change difference (Final Values)
Estimated Value
3.02
Estimation Comments
2-Sided
Secondary Outcome
Title
Pharmacokinetics (PK): Average Serum Concentration at Steady State of Donanemab
Description
The average serum concentration at steady state, calculated as Cav = AUCtau/tau, where tau is the dosing interval (4 weeks). AUCtau/tau was assessed at week 12, 16, 24, 36, 52, 64 and Cav for the dosing interval from week 16 to week 20 is reported.
Time Frame
Week 16 to week 20
Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable PK data.
Arm/Group Title
Donanemab
Overall Number of Participants Analyzed
853
Geometric Mean (Geometric Coefficient of Variation) | Unit of Measure: micrograms per milliliter (μg/mL)
63 (32)
Secondary Outcome
Title
Number or Participants With Anti-Donanemab Antibodies
Description
Number of participants with treatment-emergent positive Anti-Donanemab antibodies was summarized by treatment group.
Time Frame
Baseline through Week 76
Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable anti-drug antibody measurement.
Arm/Group Title
Donanemab
Placebo
Overall Number of Participants Analyzed
793
821
Count of Participants | Unit of Measure: Participants
693
48
Adverse Events
Time Frame
Baseline Up To 76 Weeks plus 57 Days (Follow-up period)
Adverse Event Reporting Description
Safety Population: All randomized participants who received at least one dose of study drug. There were 25 deaths reported in subject disposition and 26 deaths in All-cause mortality, because 1 participant death occurred in the plus 57-day follow-up period was considered as completer in the study disposition period. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Arm/Group Title
Donanemab
Affected / at Risk (%)
Placebo
Affected / at Risk (%)
All-Cause Mortality
Total
16 / 853 (1.88 %)
10 / 874 (1.14 %)
Serious Adverse Events
Total
148 / 853 (17.35 %)
138 / 874 (15.79 %)
Other (Not Including Serious) Adverse Events
Total
567 / 853 (66.47 %)
425 / 874 (48.63 %)
Limitations and Caveats
Not Specified
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer Organization: Eli Lilly and Company Email: ClinicalTrials.gov@lilly.com Phone: 800-545-5979