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CompletedPhase 2Results posted

A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease

Assessment of Safety, Tolerability, and Efficacy of LY3303560 in Early Symptomatic Alzheimer's Disease

Lead sponsor

Eli Lilly and Company

Asset

Zagotenemab

Listed sites

Recruiting sites

Enrollment

360

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 60-85

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID16124

Secondary IDI8G-MC-LMDCEli Lilly and Company

NCT IDNCT03518073

Timeline

Milestones

Study start2018-04-30actual

Study first posted2018-05-08actual

Primary completion2021-08-23actual

Study completion2021-10-25actual

Last update posted2022-08-30actual

Results first posted2022-08-30actual

Assets

Drug assets

Zagotenemab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Participants must have gradual and progressive change in memory function for >6 months.

•Participants must have a family member or close friend who is with you at least 10 hours per week and can attend study appointments

Exclusion criteria

•Participants must not have significant neurological disease affecting the nervous system, other than AD, that affects cognition or may affect completion of the study.

•Participants must not have serious or unstable illness that could interfere with the analysis of the study or has a life expectancy <24 months.

•Participants must not have history of cancer within the last 5 years with the exception of certain types of skin, cervical, prostate, and other cancers that are not likely to recur or spread.

•Participants must not have serious risk for suicide.

•Participants must not have history of drug or alcohol use disorder within the last 2 years.

•Participants must not have multiple severe drug allergies

•Participants must not have HIV, Hepatitis B or Hepatitis C

•Participants must not be receiving gamma globulin (IgG) or intravenous immunoglobulin (IVIG) therapy

Endpoints (18)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Function / daily living

Behavior / neuropsychiatric

Tau biomarkers

Neuroimaging

Other (unclassified)

Global cognition

6 endpoints

Secondary/protocol endpoint

Change From Baseline on the Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score

Time frame:Baseline, Week 104

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score

Time frame:Baseline, Week 104

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline on the Mini Mental Status Examination (MMSE) Score

Time frame:Baseline, Week 104

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline on the Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score

Time frame:Baseline, Week 104

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Reported bounds
Placebon=71 Participants	7.13	-6.176 - 8.104
Zagotenemab 1400 mgn=76 Participants	7.85	-6.867 - 8.848
Zagotenemab 5600 mgn=69 Participants	6.30	-5.353 - 7.262

Posterior Mean Ratio1.1195% CI0.943 - 1.290

Posterior Mean Ratio0.8995% CI0.737 - 1.053

Secondary/registry result

Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score

Time frame:Baseline, Week 104

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Reported bounds
Placebon=72 Participants	2.26	-1.976 - 2.544
Zagotenemab 1400 mgn=75 Participants	2.52	-2.233 - 2.815
Zagotenemab 5600 mgn=68 Participants	2.14	-1.854 - 2.439

Posterior Mean Ratio1.1295% CI0.963 - 1.300

Posterior Mean Ratio0.9595% CI0.805 - 1.119

Secondary/registry result

Change From Baseline on the Mini Mental Status Examination (MMSE) Score

Time frame:Baseline, Week 104

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Reported bounds
Placebon=72 Participants	-4.29	--4.858 - -3.739
Zagotenemab 1400 mgn=76 Participants	-4.44	--4.994 - -3.901
Zagotenemab 5600 mgn=68 Participants	-3.83	--4.40 - -3.265

Posterior Mean Ratio1.0495% CI0.880 - 1.221

Posterior Mean Ratio0.8995% CI0.742 - 1.065

Function / daily living

4 endpoints

Primary/protocol endpoint

Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)

Time frame:Baseline, Week 104

ADAS-Cog

change from baseline, improvement

Primary/registry result

Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)

Time frame:Baseline, Week 104

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Reported bounds
Placebon=70 Participants	-13.72	--15.325 - -12.161
Zagotenemab 1400 mgn=72 Participants	-15.11	--16.779 - -13.479
Zagotenemab 5600 mgn=68 Participants	-14.38	--16.054 - -12.727

Posterior Mean Ratio1.1095% CI0.959 - 1.265

Posterior Mean Ratio1.0595% CI0.907 - 1.209

Secondary/protocol endpoint

Change From Baseline on the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score

Time frame:Baseline, Week 104

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change From Baseline on the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score

Time frame:Baseline, Week 104

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Reported bounds
Placebon=72 Participants	-6.67	--7.730 - -5.643
Zagotenemab 1400 mgn=74 Participants	-7.06	--8.148 - -6.004
Zagotenemab 5600 mgn=69 Participants	-8.05	--9.203 - -6.922

Posterior Mean Ratio1.0695% CI0.873 - 1.284

Posterior Mean Ratio1.2195% CI1.006 - 1.453

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Number of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)

Time frame:Baseline through Week 104

event count, event

Secondary/registry result

Number of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)

Time frame:Baseline through Week 104

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PlaceboSuicidal Ideationn=118 Participants	5	-
Suicidal Behaviourn=118 Participants	1	-
Zagotenemab 1400 mgSuicidal Ideationn=126 Participants	5	-
Suicidal Behaviourn=126 Participants	2	-
Zagotenemab 5600 mgSuicidal Ideationn=116 Participants	5	-
Suicidal Behaviourn=116 Participants	0	-

Tau biomarkers

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Brain Aggregated Tau Deposition as Measured by Flortaucipir F-18 Positron Emission Tomography (PET) Scan.

Time frame:Baseline, Week 104

change from baseline, improvement

Secondary/registry result

Change From Baseline in Brain Aggregated Tau Deposition as Measured by Flortaucipir F-18 Positron Emission Tomography (PET) Scan.

Time frame:Baseline, Week 104

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), standardized uptake value ratio (SUVr)	Standard error
Placebon=62 Participants	0.08	0.012
Zagotenemab 1400 mgn=66 Participants	0.10	0.011
Zagotenemab 5600 mgn=63 Participants	0.10	0.012

LS Mean Difference0.0295% CI-0.01 - 0.05p0.253Mixed Models Analysis

LS Mean Difference0.0295% CI-0.02 - 0.05p0.354Mixed Models Analysis

Neuroimaging

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)

Time frame:Baseline, Week 104

change from baseline, improvement

Secondary/registry result

Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)

Time frame:Baseline, Week 104

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), cubic centimeter (cm^3)	Standard error
Placebon=64 Participants	-24.06	1.101
Zagotenemab 1400 mgn=65 Participants	-23.44	1.095
Zagotenemab 5600 mgn=57 Participants	-23.55	1.158

LS Mean Difference0.6295% CI-2.44 - 3.68p0.691Mixed Models Analysis

LS Mean Difference0.5195% CI-2.64 - 3.66p0.749Mixed Models Analysis

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Zagotenemab

Time frame:Baseline through Week 113

event count, event

Secondary/registry result/low confidence

Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Zagotenemab

Time frame:Baseline through Week 113

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Zagotenemab 1400 mgn=126 Participants	2	-
Zagotenemab 5600 mgn=115 Participants	1	-

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Fleisher AS, Munsie LM, Perahia DGS, Andersen SW, Higgins IA, Hauck PM, Lo AC, Sims JR, Brys M, Mintun M; PERISCOPE-ALZ Site Investigators. Assessment of Efficacy and Safety of Zagotenemab: Results From PERISCOPE-ALZ, a Phase 2 Study in Early Symptomatic Alzheimer Disease. Neurology. 2024 Mar 12;102(5):e208061. doi: 10.1212/WNL.0000000000208061. Epub 2024 Feb 22.
PMID38386949via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.