Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

ClinicalTrials.gov processed this data on September 20, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

ACTIVE, NOT RECRUITING - HAS RESULTS
(See Contacts and Locations)
Verified September 2024 by Eli Lilly and Company

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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Study TypeInterventional
Study DesignAllocation: Randomized; Interventional Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
Condition(s)
  • Alzheimer Disease
Intervention(s)
  • Drug: Donanemab
  • Drug: Placebo
Enrollment1736

Participant Flow

Arm/Group TitleDonanemab Placebo
Overall Study
STARTED860876
Received at Least One Dose of Drug (Safety Population)853874
COMPLETED622698
NOT COMPLETED238178
Adverse Event5021
Death1510
Lost to Follow-up1111
Physician Decision1910
Progressive Disease47
Withdrawal by Subject11194
Withdrawal due to Caregiver Circumstances2120
Continuing Study75

Baseline Characteristics

Arm/Group TitleDonanemabPlaceboTotal
Overall Number of Baseline Participants8608761736
Age, Continuous | Measure Type: Mean | Unit of measure: years
Number Analyzed860 years876 years1736 years
72.98 (8.5%)73.04 (8.3%)73.01 (4.2%)
Sex/Gender, Customized | Measure Type: Number | Unit of measure: participants
Number Analyzed853 participants874 participants1727 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 Analyzed860 participants876 participants1736 participants
Female493 (57.3%)503 (57.4%)996 (57.4%)
Male367 (42.7%)373 (42.6%)740 (42.6%)
Ethnicity (NIH/OMB) | Measure Type: Count of Participants | Unit of measure: Participants
Number Analyzed860 participants876 participants1736 participants
Hispanic or Latino35 (4.1%)36 (4.1%)71 (4.1%)
Not Hispanic or Latino583 (67.8%)594 (67.8%)1177 (67.8%)
Unknown or Not Reported242 (28.1%)246 (28.1%)488 (28.1%)
Race (NIH/OMB) | Measure Type: Count of Participants | Unit of measure: Participants
Number Analyzed860 participants876 participants1736 participants
American Indian or Alaska Native2 (0.2%)2 (0.1%)
Asian57 (6.6%)47 (5.4%)104 (6%)
Native Hawaiian or Other Pacific Islander
Black or African American19 (2.2%)21 (2.4%)40 (2.3%)
White781 (90.8%)807 (92.1%)1588 (91.5%)
More than one race1 (0.1%)1 (0.1%)
Unknown or Not Reported1 (0.1%)1 (0.1%)
Region of Enrollment | Measure Type: Count of Participants | Unit of measure: Participants
Number Analyzed860 participants876 participants1736 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 Analyzed860 score on a scale876 score on a scale1736 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 Analyzed859 participants875 participants1734 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

TitleChange From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population)
DescriptionIntegrated 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 FrameBaseline, Week 76
Analysis Population DescriptionAll randomized participants with a baseline and at least one postbaseline iADRS data point.
Arm/Group TitleDonanemabPlacebo
Overall Number of Participants Analyzed775824
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 SelectionDonanemab, Placebo
Type of Statistical TestSuperiority
Statistical Test of Hypothesis
P-Value<0.001
MethodMixed Models Analysis
Method of Estimation
Estimation ParameterLS Mean change difference (Final Values)
Estimated Value2.92
Estimation Comments2-Sided

Primary Outcome

TitleChange From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population)
DescriptionIntegrated 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 FrameBaseline, Week 76
Analysis Population DescriptionAll randomized participants with baseline Intermediate Tau level and with baseline and at least one postbaseline iADRS data point.
Arm/Group TitleDonanemabPlacebo
Overall Number of Participants Analyzed533560
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 SelectionDonanemab, Placebo
Type of Statistical TestSuperiority
Statistical Test of Hypothesis
P-Value<0.001
MethodMixed Models Analysis
Method of Estimation
Estimation ParameterLS Mean change difference (Final Values)
Estimated Value3.25
Estimation Comments2-Sided

Secondary Outcome

TitleChange From Baseline on the Mini Mental State Examination (MMSE) Score (Overall Population)
DescriptionMMSE 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 FrameBaseline, Week 76
Analysis Population DescriptionAll randomized participants with a baseline and at least one postbaseline MMSE data point.
Arm/Group TitleDonanemabPlacebo
Overall Number of Participants Analyzed796841
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 SelectionDonanemab, Placebo
Type of Statistical TestSuperiority
Statistical Test of Hypothesis
P-Value0.012
MethodMixed Models Analysis
Method of Estimation
Estimation ParameterLS Mean change difference (Final Values)
Estimated Value0.47
Estimation Comments2-Sided

Secondary Outcome

TitleChange From Baseline on the Mini Mental State Examination (MMSE) Score (Intermediate (Low-medium) Tau Population)
DescriptionMMSE 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 FrameBaseline, Week 76
Analysis Population DescriptionAll randomized participants with baseline Intermediate Tau level and with baseline and at least one postbaseline MMSE data point.
Arm/Group TitleDonanemabPlacebo
Overall Number of Participants Analyzed549573
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 SelectionDonanemab, Placebo
Type of Statistical TestSuperiority
Statistical Test of Hypothesis
P-Value0.016
MethodMixed Models Analysis
Method of Estimation
Estimation ParameterLS Mean change difference (Final Values)
Estimated Value0.48
Estimation Comments2-Sided

Secondary Outcome

TitleChange From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Overall Population)
DescriptionThe 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 FrameBaseline, Week 76
Analysis Population DescriptionAll randomized participants with a baseline and at least one postbaseline ADAS-Cog13 data point.
Arm/Group TitleDonanemabPlacebo
Overall Number of Participants Analyzed797841
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 SelectionDonanemab, Placebo
Type of Statistical TestSuperiority
Statistical Test of Hypothesis
P-Value0.0006
MethodMixed Models Analysis
Method of Estimation
Estimation ParameterLS Mean change difference (Final Values)
Estimated Value-1.33
Estimation Comments2-Sided

Secondary Outcome

TitleChange From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Intermediate (Low-medium) Tau Population)
DescriptionThe 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 FrameBaseline, Week 76
Analysis Population DescriptionAll randomized participants with baseline Intermediate Tau level and with baseline and at least one postbaseline ADAS-Cog13 data point.
Arm/Group TitleDonanemabPlacebo
Overall Number of Participants Analyzed550570
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 SelectionDonanemab, Placebo
Type of Statistical TestSuperiority
Statistical Test of Hypothesis
P-Value<0.001
MethodMixed Models Analysis
Method of Estimation
Estimation ParameterLS Mean change difference (Final Values)
Estimated Value-1.52
Estimation Comments2-Sided

Secondary Outcome

TitleChange From Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (Overall Population)
DescriptionCDR-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 FrameBaseline, Week 76
Analysis Population DescriptionAll randomized participants with a baseline and at least one postbaseline CDR-SB data point.
Arm/Group TitleDonanemabPlacebo
Overall Number of Participants Analyzed794838
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 SelectionDonanemab, Placebo
Type of Statistical TestSuperiority
Statistical Test of Hypothesis
P-Value<0.001
MethodMixed Models Analysis
Method of Estimation
Estimation ParameterLS Mean change difference (Final Values)
Estimated Value-0.70
Estimation Comments2-Sided

Secondary Outcome

TitleChange From Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (Intermediate (Low-medium) Tau Population)
DescriptionCDR-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 FrameBaseline, Week 76
Analysis Population DescriptionAll randomized participants with baseline Intermediate Tau level and with baseline and at least one postbaseline CDR-SB data point.
Arm/Group TitleDonanemabPlacebo
Overall Number of Participants Analyzed546569
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 SelectionDonanemab, Placebo
Type of Statistical TestSuperiority
Statistical Test of Hypothesis
P-Value<0.001
MethodMixed Models Analysis
Method of Estimation
Estimation ParameterLS Mean change difference (Final Values)
Estimated Value-0.67
Estimation Comments2-Sided

Secondary Outcome

TitleChange From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) Score (Overall Population)
DescriptionThe 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 FrameBaseline, Week 76
Analysis Population DescriptionAll randomized participants with a baseline and at least one postbaseline ADCS-iADL data point.
Arm/Group TitleDonanemabPlacebo
Overall Number of Participants Analyzed780826
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 SelectionDonanemab, Placebo
Type of Statistical TestSuperiority
Statistical Test of Hypothesis
P-Value0.0001
MethodMixed Models Analysis
Method of Estimation
Estimation ParameterLS Mean change difference (Final Values)
Estimated Value1.70
Estimation Comments2-Sided

Secondary Outcome

TitleChange From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) Score (Intermediate (Low-medium) Tau Population)
DescriptionThe 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 FrameBaseline, Week 76
Analysis Population DescriptionAll randomized participants with a baseline Intermediate Tau level and with baseline and at least one postbaseline ADCS-iADL data point.
Arm/Group TitleDonanemabPlacebo
Overall Number of Participants Analyzed535562
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 SelectionDonanemab, Placebo
Type of Statistical TestSuperiority
Statistical Test of Hypothesis
P-Value<0.001
MethodMixed Models Analysis
Method of Estimation
Estimation ParameterLS Mean change difference (Final Values)
Estimated Value1.83
Estimation Comments2-Sided

Secondary Outcome

TitleChange From Baseline in Brain Amyloid Plaque Deposition as Measured by Amyloid Positron Emission Tomography (PET) Scan
DescriptionAmyloid 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 FrameBaseline, Week 76
Analysis Population DescriptionAll randomized participants with a baseline and at least one postbaseline amyloid PET scan data point.
Arm/Group TitleDonanemabPlacebo
Overall Number of Participants Analyzed765812
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 SelectionDonanemab, Placebo
Type of Statistical TestSuperiority
Statistical Test of Hypothesis
P-Value<0.0001
MethodMixed Models Analysis
Method of Estimation
Estimation ParameterLS Mean change difference (Final Values)
Estimated Value-86.37
Estimation Comments2-Sided

Secondary Outcome

TitleChange From Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET Scan
DescriptionFlortaucipir 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 FrameBaseline, Week 76
Analysis Population DescriptionAll randomized participants with a baseline and post-baseline tau PET scan.
Arm/Group TitleDonanemabPlacebo
Overall Number of Participants Analyzed578654
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 SelectionDonanemab, Placebo
Type of Statistical TestSuperiority
Statistical Test of Hypothesis
P-Value0.4522
MethodANCOVA
Method of Estimation
Estimation ParameterLS Mean change difference (Final Values)
Estimated Value-0.0041
Estimation Comments2-Sided

Secondary Outcome

TitleChange From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)
DescriptionMRI 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 FrameBaseline, Week 76
Analysis Population DescriptionAll randomized participants with a baseline and at least one postbaseline vMRI data point.
Arm/Group TitleDonanemabPlacebo
Overall Number of Participants Analyzed786831
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 Ventricles10.07 (0.185)7.05 (0.178)

Statistical Analysis 1

Statistical Analysis Overview
Comparison Group SelectionDonanemab, Placebo
CommentsBilateral Hippocampus
Type of Statistical TestSuperiority
Statistical Test of Hypothesis
P-Value0.002
MethodMixed Models Analysis
Method of Estimation
Estimation ParameterLS Mean change difference (Final Values)
Estimated Value0.02
Estimation Comments2-Sided

Statistical Analysis 2

Statistical Analysis Overview
Comparison Group SelectionDonanemab, Placebo
CommentsBilateral Whole Brain
Type of Statistical TestSuperiority
Statistical Test of Hypothesis
P-Value<0.001
MethodMixed Models Analysis
Method of Estimation
Estimation ParameterLS Mean change difference (Final Values)
Estimated Value-6.66
Estimation Comments2-Sided

Statistical Analysis 3

Statistical Analysis Overview
Comparison Group SelectionDonanemab, Placebo
CommentsBilateral Ventricles
Type of Statistical TestSuperiority
Statistical Test of Hypothesis
P-Value<0.001
MethodMixed Models Analysis
Method of Estimation
Estimation ParameterLS Mean change difference (Final Values)
Estimated Value3.02
Estimation Comments2-Sided

Secondary Outcome

TitlePharmacokinetics (PK): Average Serum Concentration at Steady State of Donanemab
DescriptionThe 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 FrameWeek 16 to week 20
Analysis Population DescriptionAll randomized participants who received at least one dose of study drug and had evaluable PK data.
Arm/Group TitleDonanemab
Overall Number of Participants Analyzed853
Geometric Mean (Geometric Coefficient of Variation) | Unit of Measure: micrograms per milliliter (μg/mL)
63 (32)

Secondary Outcome

TitleNumber or Participants With Anti-Donanemab Antibodies
DescriptionNumber of participants with treatment-emergent positive Anti-Donanemab antibodies was summarized by treatment group.
Time FrameBaseline through Week 76
Analysis Population DescriptionAll randomized participants who received at least one dose of study drug and had evaluable anti-drug antibody measurement.
Arm/Group TitleDonanemabPlacebo
Overall Number of Participants Analyzed793821
Count of Participants | Unit of Measure: Participants
69348

Adverse Events

Time FrameBaseline Up To 76 Weeks plus 57 Days (Follow-up period)
Adverse Event Reporting DescriptionSafety 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 TitleDonanemab

Affected / at Risk (%)

Placebo

Affected / at Risk (%)

All-Cause Mortality
Total16 / 853 (1.88 %)10 / 874 (1.14 %)
Serious Adverse Events
Total148 / 853 (17.35 %)138 / 874 (15.79 %)
Other (Not Including Serious) Adverse Events
Total567 / 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