A Phase 2 interventional study of Donanemab and Placebo in Alzheimer Disease, sponsored by Eli Lilly and Company. Completed at 61 sites in 2 countries. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
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Among 15 studies testing donanemab in Alzheimer Disease — 7 open to participants now, 10 under way, 6 of them phase 3. donanemab · Alzheimer Disease.
Among the 15 studies testing donanemab in Alzheimer Disease, this one is the 7th largest by enrollment, is the only one that started in 2017, is one of 4 in phase 2, and was the 3rd registered.
3,968 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.
Browse Alzheimer Disease studies →7 of the 15 studies testing donanemab in Alzheimer Disease are open now, in 8 countries. Recruiting first, the newest first:
Banner Health · Sites in Colombia
Ages 25–65 · Healthy volunteers
Eli Lilly and Company · Sites in United States, Japan, Puerto Rico
Ages 55+
Eli Lilly and Company · Sites in United States, Japan, Korea, Republic of and 1 more country
Ages 55–85
Eli Lilly and Company · Sites in China
Ages 55–80
Paul S. Aisen · Sites in United States
Ages 50–80
By country, each count listing its studies:
donanemab: first FDA approval 2024 (KISUNLA), first EMA approval 2025. What it is approved for, and how studies give it, is on its page →
Of the 643 Alzheimer Disease studies recruiting now, 284 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 285 take healthy volunteers.
This study: 60 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 5 · Phase 3 7 · Phase 4 2
First in 2013; this study’s year is marked. 1 started in 2017.
This study's enrollment of 272 is above the median of 70 across 3,021 interventional studies indexed under Alzheimer Disease.
Median enrollment 240 across the 15 interventional studies. Of the 5 that completed or were terminated, 5 (100%) have results posted.
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12 of 15 have an industry lead sponsor. The 4 most frequent:
Eli Lilly and Company is the lead sponsor of 2,108 studies on the registry; 153 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 358 (67%) have results posted.
99 studies in Alzheimer Disease by Eli Lilly and Company: 13 open now, 19 under way, 8 of them phase 3. Of 79 finished, 61 (77%) have results posted.
Among the 99 studies in Alzheimer Disease by Eli Lilly and Company, this one is the 23rd largest by enrollment of the 95 interventional ones that give a count, is one of 3 that started in 2017, is one of 23 in phase 2, and was the 68th registered.
Eli Lilly and Company’s Alzheimer Disease studies by the year they started, since 2002.
1 of the studies testing donanemab in Alzheimer Disease that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05026866Phase 3Eli Lilly and CompanyA Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3) | 2027-11 |
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Among the 15 studies testing donanemab in Alzheimer Disease, from their registry updates:
Among Eli Lilly and Company’s 99 in Alzheimer Disease:
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The purpose of this study is to evaluate the safety, tolerability and efficacy of LY3002813 in early symptomatic Alzheimer's disease.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received 700 milligram (mg) donanemab intravenously (IV) every 4 weeks (Q4W) x 3 doses, then 1400 mg donanemab IV Q4W for up to 72 weeks.
Drug: Donanemab
Participants received placebo IV Q4W for up to 72 weeks.
Drug: Placebo
Participants received 700 mg donanemab IV Q4W x 3 doses, then 1400 mg donanemab IV Q4W in combination with 12 mg of LY3202626 orally for up to 72 weeks. As per protocol amendment (d) approved on Oct 9, 2018, donanemab in combination with LY3202626 (donanemab-C) arm discontinued as there was a low probability of identifying a statistically significant effect of 12mg of LY3202626 slowing cognitive decline.
Drug: Donanemab · Drug: LY3202626
Change From Baseline in the Integrated Alzheimer's Disease Rating Scale (iADRS) Score
Integrated Alzheimer's Disease Rating Scale is used to assess whether donanemab slows down the cognitive and functional decline associated with AD compared with placebo. iADRS is a simple linear combination of 13-item 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. Least Squares (LS) Mean value was controlled for fixed, categorical effects of treatment, visit and treatment-by-visit interaction, pooled investigator, acetylcholinesterase inhibitor (AChEI) and/or memantine use at baseline, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
Time frame: Baseline, 76 Weeks
Change From Baseline in the 13-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) Score
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 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 controlled for fixed, categorical effects of treatment, visit and treatment-by-visit interaction, pooled investigator, AChEI and/or memantine use at baseline, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
Time frame: Baseline, 76 Weeks
Change From Baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score
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 controlled for fixed, categorical effects of treatment, visit and treatment-by-visit interaction, pooled investigator, AChEI and/or memantine use at baseline, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
Time frame: Baseline, 76 Weeks
Change From Baseline in the Mini Mental State Examination (MMSE) Score
MMSE is a brief screening 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 controlled for fixed, categorical effects of treatment, visit and treatment-by-visit interaction, pooled investigator, AChEI and/or memantine use at baseline, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
Time frame: Baseline, 76 Weeks
Change From Baseline in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score
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 controlled for fixed, categorical effects of treatment, visit and treatment-by-visit interaction, pooled investigator, AChEI and/or memantine use at baseline, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
Time frame: Baseline, 76 Weeks
Change From Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 Positron Emission Tomography (PET) Scan
Florbetapir PET imaging was used as a quantitative amyloid biomarker. Florbetapir 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 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. Least Squares mean change was controlled for fixed, categorical effects of treatment, visit and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
Time frame: Baseline, 76 Weeks
Change From Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET Scan
Flortaucipir PET imaging was used as a quantitative tau biomarker. Flortaucipir 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 two measures: weighted average Standardized Uptake Value Ratio (MUBADA SUVR) in the brain relative to the cerebellum gray as a reference region and the global tau load (TauL) generated using a TauIQ method. Larger weighted average SUVR reflects the larger cortical tau burden relative to cerebellum gray. The TauIQ method quantifies the spatiotemporal accumulation pattern of tau and larger TauL value reflects the larger global tau level in the brain as determined using a TauIQ mathematical framework. Least Squares mean change was controlled for baseline + age + treatment (Type III sum of squares).
Time frame: Baseline, 76 Weeks
Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)
MRI scans at baseline and at 76 weeks after the first treatment were used to quantitatively estimate change in brain atrophy. Volumetric MRI (vMRI) parameters were measured in 14 brain regions: bilateral cortical, bilateral entorhinal cortex, bilateral hippocampus, bilateral inferior parietal lobe, bilateral isthmus cingulate, bilateral lateral parietal lobe, bilateral medial temporal lobe, bilateral precuneus, bilateral prefrontal lobe, bilateral superior temporal lobe, bilateral ventricles, bilateral whole brain, bilateral whole temporal lobe, and bilateral white matter. The atrophy was assessed by tensor-based morphometry, which captures volume changes within the deformation map. LS Mean value was controlled for fixed, categorical effects of treatment, visit and treatment-by-visit interaction, fixed covariates of baseline, and age at baseline.
Time frame: Baseline, 76 Weeks
As per protocol amendment (d) approved on Oct 9, 2018, donanemab in combination with LY3202626 (donanemab-C) arm discontinued as there was a low probability of identifying a statistically significant effect of 12 milligram (mg) of LY3202626 slowing cognitive decline. Clinical efficacy was not reported for this group.
| Milestone | Donanemab Monotherapy (Donanemab-M) | Placebo | Donanemab in Combination With LY3202626 (Donanemab-C) |
|---|---|---|---|
| Started | 131 | 126 | 15 |
| Received at least one dose of study drug | 131 | 125 | 15 |
| Completed | 94 | 93 | 12 |
| Not completed | 37 | 33 | 3 |
| Withdrew: Adverse event | 20 | 6 | 2 |
| Withdrew: Withdrawal by subject | 12 | 13 | 1 |
| Withdrew: Death | 1 | 2 | 0 |
| Withdrew: Physician decision | 0 | 1 | 0 |
| Withdrew: Protocol violation | 1 | 1 | 0 |
| Withdrew: Withdrawal due to caregiver circumstances | 0 | 2 | 0 |
| Withdrew: Covid-19 | 3 | 6 | 0 |
| Withdrew: Abuse of alcohol intake | 0 | 1 | 0 |
| Withdrew: Subject and study partner do not believe study has been beneficial and cognition has declined | 0 | 1 | 0 |
Integrated Alzheimer's Disease Rating Scale is used to assess whether donanemab slows down the cognitive and functional decline associated with AD compared with placebo. iADRS is a simple linear combination of 13-item 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. Least Squares (LS) Mean value was controlled for fixed, categorical effects of treatment, visit and treatment-by-visit interaction, pooled investigator, acetylcholinesterase inhibitor (AChEI) and/or memantine use at baseline, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
| score on a scale | Donanemab Monotherapy (Donanemab-M) | Placebo |
|---|---|---|
| Change From Baseline in the Integrated Alzheimer's Disease Rating Scale (iADRS) Score | -6.86 ± 1.135 | -10.06 ± 1.141 |
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 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 controlled for fixed, categorical effects of treatment, visit and treatment-by-visit interaction, pooled investigator, AChEI and/or memantine use at baseline, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
| score on a scale | Donanemab Monotherapy (Donanemab-M) | Placebo |
|---|---|---|
| Change From Baseline in the 13-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) Score | 2.91 ± 0.659 | 4.77 ± 0.660 |
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 controlled for fixed, categorical effects of treatment, visit and treatment-by-visit interaction, pooled investigator, AChEI and/or memantine use at baseline, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
| score on a scale | Donanemab Monotherapy (Donanemab-M) | Placebo |
|---|---|---|
| Change From Baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score | 1.22 ± 0.176 | 1.58 ± 0.178 |
MMSE is a brief screening 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 controlled for fixed, categorical effects of treatment, visit and treatment-by-visit interaction, pooled investigator, AChEI and/or memantine use at baseline, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
| score on a scale | Donanemab Monotherapy (Donanemab-M) | Placebo |
|---|---|---|
| Change From Baseline in the Mini Mental State Examination (MMSE) Score | -2.35 ± 0.386 | -2.98 ± 0.390 |
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 controlled for fixed, categorical effects of treatment, visit and treatment-by-visit interaction, pooled investigator, AChEI and/or memantine use at baseline, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
| score on a scale | Donanemab Monotherapy (Donanemab-M) | Placebo |
|---|---|---|
| Change From Baseline in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score | -3.98 ± 0.738 | -5.20 ± 0.743 |
Florbetapir PET imaging was used as a quantitative amyloid biomarker. Florbetapir 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 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. Least Squares mean change was controlled for fixed, categorical effects of treatment, visit and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
| centiloids | Donanemab Monotherapy (Donanemab-M) | Placebo |
|---|---|---|
| Change From Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 Positron Emission Tomography (PET) Scan | -84.13 ± 2.723 | 0.93 ± 2.739 |
Flortaucipir PET imaging was used as a quantitative tau biomarker. Flortaucipir 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 two measures: weighted average Standardized Uptake Value Ratio (MUBADA SUVR) in the brain relative to the cerebellum gray as a reference region and the global tau load (TauL) generated using a TauIQ method. Larger weighted average SUVR reflects the larger cortical tau burden relative to cerebellum gray. The TauIQ method quantifies the spatiotemporal accumulation pattern of tau and larger TauL value reflects the larger global tau level in the brain as determined using a TauIQ mathematical framework. Least Squares mean change was controlled for baseline + age + treatment (Type III sum of squares).
| standardized uptake value ratio (SUVR) | Donanemab Monotherapy (Donanemab-M) | Placebo |
|---|---|---|
| Tau-IQ | 0.55 ± 0.007 | 0.55 ± 0.007 |
| MUBADA-Cerebellum | 1.54 ± 0.009 | 1.58 ± 0.010 |
MRI scans at baseline and at 76 weeks after the first treatment were used to quantitatively estimate change in brain atrophy. Volumetric MRI (vMRI) parameters were measured in 14 brain regions: bilateral cortical, bilateral entorhinal cortex, bilateral hippocampus, bilateral inferior parietal lobe, bilateral isthmus cingulate, bilateral lateral parietal lobe, bilateral medial temporal lobe, bilateral precuneus, bilateral prefrontal lobe, bilateral superior temporal lobe, bilateral ventricles, bilateral whole brain, bilateral whole temporal lobe, and bilateral white matter. The atrophy was assessed by tensor-based morphometry, which captures volume changes within the deformation map. LS Mean value was controlled for fixed, categorical effects of treatment, visit and treatment-by-visit interaction, fixed covariates of baseline, and age at baseline.
| cubic centimeter (cm^3) | Donanemab Monotherapy (Donanemab-M) | Placebo |
|---|---|---|
| Bilateral Cortical | -11.18 ± 0.447 | -8.51 ± 0.445 |
| Bilateral Entorhinal Cortex | -0.17 ± 0.008 | -0.17 ± 0.008 |
| Bilateral Hippocampus | -0.22 ± 0.013 | -0.22 ± 0.013 |
| Bilateral Inferior Parietal Lobe | -0.53 ± 0.033 | -0.45 ± 0.033 |
| Bilateral Isthmuscingulate | -0.15 ± 0.008 | -0.13 ± 0.008 |
| Bilateral Lateral Parietal Lobe | -1.60 ± 0.084 | -1.26 ± 0.083 |
| Bilateral Medial Temporal Lobe | -0.73 ± 0.025 | -0.72 ± 0.025 |
| Bilateral Precuneus | -0.71 ± 0.032 | -0.55 ± 0.032 |
| Bilateral Prefrontal Lobe | -1.50 ± 0.081 | -1.11 ± 0.080 |
| Bilateral Superior Temporal Lobe | -0.73 ± 0.031 | -0.52 ± 0.031 |
| Bilateral Ventricles | 8.66 ± 0.412 | 6.38 ± 0.410 |
| Bilateral Whole Brain | -24.53 ± 1.077 | -19.95 ± 1.072 |
| Bilateral Whole Temporal Lobe | -3.52 ± 0.126 | -2.84 ± 0.126 |
| Bilateral White Matter | -11.03 ± 0.700 | -8.75 ± 0.696 |
Collected over Baseline Up To 124 Weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Donanemab Monotherapy (Donanemab-M) | 1/131 (0.8%) | 26/131 (19.8%) | 118/131 (90.1%) |
| Placebo | 2/125 (1.6%) | 25/125 (20%) | 112/125 (89.6%) |
| Donanemab in Combination With LY3202626 (Donanemab-C) | 0/15 (0%) | 3/15 (20%) | 15/15 (100%) |
| Event | Donanemab Monotherapy (Donanemab-M) | Placebo | Donanemab in Combination With LY3202626 (Donanemab-C) |
|---|---|---|---|
| VertigoEar and labyrinth disorders | 0/131 | 0/125 | 1/15 |
| NauseaGastrointestinal disorders | 0/131 | 0/125 | 1/15 |
| Urinary tract infectionInfections and infestations | 0/131 | 1/125 | 1/15 |
| UrosepsisInfections and infestations | 0/131 | 0/125 | 1/15 |
| DehydrationMetabolism and nutrition disorders | 2/131 | 1/125 | 1/15 |
| Type 2 diabetes mellitusMetabolism and nutrition disorders | 0/131 | 0/125 | 1/15 |
| Intervertebral disc degenerationMusculoskeletal and connective tissue disorders | 0/131 | 0/125 | 1/15 |
| Subarachnoid haemorrhageNervous system disorders | 0/131 | 0/125 | 1/15 |
| AnxietyPsychiatric disorders | 0/131 | 0/125 | 1/15 |
| Mental disorder due to a general medical conditionPsychiatric disorders | 0/131 | 0/125 | 1/15 |
| Event | Donanemab Monotherapy (Donanemab-M) | Placebo | Donanemab in Combination With LY3202626 (Donanemab-C) |
|---|---|---|---|
| Amyloid related imaging abnormality-oedema/effusionNervous system disorders | 33/131 | 1/125 | 4/15 |
| DizzinessNervous system disorders | 11/131 | 14/125 | 4/15 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 12/131 | 10/125 | 3/15 |
| Superficial siderosis of central nervous systemNervous system disorders | 18/131 | 4/125 | 3/15 |
| FallInjury, poisoning and procedural complications | 19/131 | 21/125 | 1/15 |
| CellulitisInfections and infestations | 2/131 | 2/125 | 2/15 |
| Upper respiratory tract infectionInfections and infestations | 9/131 | 9/125 | 2/15 |
| Urinary tract infectionInfections and infestations | 13/131 | 4/125 | 2/15 |
| Cerebral microhaemorrhageNervous system disorders | 10/131 | 3/125 | 2/15 |
| ParaesthesiaNervous system disorders | 1/131 | 0/125 | 2/15 |
All randomized participants.
| Age, Continuous(years) | Donanemab Monotherapy (Donanemab-M) | Placebo | Donanemab in Combination With LY3202626 (Donanemab-C) | Total |
|---|---|---|---|---|
| Mean | 74.95 ± 5.58 | 75.35 ± 5.43 | 75.20 ± 5.99 | 75.15 ± 5.52 |
| Sex: Female, Male(Participants) | Donanemab Monotherapy (Donanemab-M) | Placebo | Donanemab in Combination With LY3202626 (Donanemab-C) | Total |
|---|---|---|---|---|
| Female | 68 | 65 | 12 | 145 |
| Male | 63 | 61 | 3 | 127 |
| Ethnicity (NIH/OMB)(Participants) | Donanemab Monotherapy (Donanemab-M) | Placebo | Donanemab in Combination With LY3202626 (Donanemab-C) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 5 | 3 | 1 | 9 |
| Not Hispanic or Latino | 126 | 123 | 14 | 263 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Donanemab Monotherapy (Donanemab-M) | Placebo | Donanemab in Combination With LY3202626 (Donanemab-C) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 0 | 2 |
| Asian | 1 | 2 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 5 | 3 | 0 | 8 |
| White | 122 | 121 | 15 | 258 |
| More than one race | 1 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Donanemab Monotherapy (Donanemab-M) | Placebo | Donanemab in Combination With LY3202626 (Donanemab-C) | Total |
|---|---|---|---|---|
| Canada | 10 | 11 | 0 | 21 |
| United States | 121 | 115 | 15 | 251 |
| Integrated Alzheimer's Disease Rating Scale (iADRS)(score on a scale) | Donanemab Monotherapy (Donanemab-M) | Placebo | Donanemab in Combination With LY3202626 (Donanemab-C) | Total |
|---|---|---|---|---|
| Mean | 106.20 ± 13.03 | 105.88 ± 13.22 | 108.93 ± 10.17 | 106.20 ± 12.96 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
Data sharing details ↗ · vivli.org
Ran from Dec 2017 to primary completion in Dec 2020, 35 months.
Results were first posted in Feb 2022, 1 year 2 months after primary completion.
Of 130 industry-sponsored phase 2 interventional studies under Alzheimer Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 39. This study's 35 months is above that.
Counting every sponsor, half of 257 studies reached it within 37 months; a quarter within 21 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Donanemab