Alzheimer DiseasePhase 1NCT02624778
A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer's Disease (AD) or AD
A Phase 1 study testing LY3002813 in people with Alzheimer Disease, run by Eli Lilly and Company at 9 sites in 2 countries.
Trial summary
The study will evaluate the effect of LY3002813 on brain scans. The study will evaluate the safety of LY3002813 by looking at adverse events (side effects). The study will also look at the effect the body has on LY3002813. Study participants will have mild cognitive impairment (MCI) due to AD or mild to moderate AD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- LY3002813
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 22 Dec 2015to 28 Aug 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild-to-moderate AD
- Men or nonfertile women, at least 50 years of age. Nonfertile is defined as hysterectomy and/or bilateral oophorectomy, or amenorrhea for at least 1 year
- Have up to 2 partners who will provide a separate written informed consent to participate
- Have adequate vision and hearing for neuropsychological testing in the opinion of the investigator
- Positive florbetapir scan
Who cannot join
- Do not have up to 2 reliable partners who are in frequent contact with the participant, who will accompany the participant to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications
- Are being monitored for radiation due to occupational exposure to ionized radiation, or exposure to ionizing radiation within last 12 months from an investigational study
- History of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, or stroke or epilepsy
- Have any contraindications for magnetic resonance imaging (MRI) studies, including claustrophobia, the presence of contraindicated metal (ferromagnetic) implants, cardiac pacemaker
- Have allergies to humanized monoclonal antibodies, including proteins and diphenhydramine, epinephrine, and methylprednisolone
- Have gamma globulin therapy within the last year
Show all 9Show fewer
- Previously dosed in any other study investigating active immunization against amyloid beta (Aβ)
- Previously dosed in any other study investigating passive immunization against Aβ within the last 6 months
- Have current serious or unstable illnesses
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States6 sites
SNBL Clinical Pharmacology Center Inc
Baltimore, Maryland, 21201
Brain Matters Research
Delray Beach, Florida, 33445
Compass Research
Orlando, Florida, 32806
PRA Health Sciences
Salt Lake City, Utah, 84106
St. Louis Clinical Trials, LC
St Louis, Missouri, 63141
Compass Research
The Villages, Florida, 32162
Japan3 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Shinjuku-Ku, 162-0053
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Shinjuku-Ku, 169-0073
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Sumida-ku, 130-0004
About this study
Official title: A Single- and Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Intravenous Doses of LY3002813 in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease
The study will evaluate the effect of LY3002813 on brain scans. The study will evaluate the safety of LY3002813 by looking at adverse events (side effects). The study will also look at the effect the body has on LY3002813. Study participants will have mild cognitive impairment (MCI) due to AD or mild to moderate AD.
The study involves 3 parts.
Read more
- Part A in which participants will receive a single dose of LY3002813 or placebo (no drug).
- Part B in which participants will receive multiple doses of LY3002813 or placebo for 24 weeks.
- Part C in which participants will receive multiple doses of LY3002813 or placebo for up to 72 weeks.
Drug will be given as an intravenous infusion (injection into a vein). For Parts A, B and C, the study will last approximately 72 weeks, not including screening of approximately 56 days. The study is for research purposes only and is not intended to treat any medical condition.
- Conditions
- Alzheimer Disease
- Being tested
- LY3002813, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3002813Biological
Administered IV
PlaceboDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Part A: Placebo Single Dose (SD) | Placebo comparator | Participants received single intravenous (IV) dose of placebo. Receives: Drug: Placebo |
| Part A: 10 Milligram Per Kilogram (mg/kg) LY3002813 SD | Experimental | Participants received single IV dose of 10 mg/kg LY3002813. Receives: Biological: LY3002813 |
| Part A: 20 mg/kg LY3002813 SD | Experimental | Participants received single IV dose of 20 mg/kg LY3002813. Receives: Biological: LY3002813 |
| Part A: 40 mg/kg LY3002813 SD | Experimental | Participants received single IV dose of 40 mg/kg LY3002813. Receives: Biological: LY3002813 |
| Part B: Placebo Q2W | Placebo comparator | Participants received multiple IV dose of placebo every 2 weeks (Q2W) for 24 weeks. Receives: Drug: Placebo |
| Part B: 10 mg/kg LY3002813 Q2W | Experimental | Participants received multiple IV dose of 10 mg/kg LY3002813 Q2W for 24 weeks. Receives: Biological: LY3002813 |
| Part C: Placebo Q4W | Placebo comparator | Participants received multiple IV dose of placebo every 4 weeks (Q4W) for 72 weeks. Receives: Drug: Placebo |
| Part C:10 mg/kg LY3002813 Q4W | Experimental | Participants received multiple IV dose of 10 mg/kg LY3002813 Q4W for 72 weeks. Receives: Biological: LY3002813 |
| Part C:20 mg/kg LY3002813 Q4W | Experimental | Participants received multiple IV dose of 20 mg/kg LY3002813 Q4W for 72 weeks. Receives: Biological: LY3002813 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan Standard Uptake Value Ratio (SUVr)
Florbetapir PET imaging was used to confirm the presence of amyloid pathology consistent with AD. Change from baseline was done to test the hypothesis that amyloid burden was reduced in participants in the treatment group. The change from baseline to the postbaseline visit of the composite summary standard uptake value ratio of florbetapir F18 was calculated. Least square (LS) mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. The composite summary measure is an unweighted average of the 6 smaller regions (anterior cingulate, frontal medial orbital, parietal, posterior cingulate, precuneus, and temporal) normalized to whole cerebellum or subject-specific white matter.
Measured: Baseline, Week 72
Secondary outcomes (6)
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)] in Part A
Area under the curve from time zero to last quantifiable concentration [AUC (0-tlast)] at day 1 was reported.
Measured: Predose, end of infusion, 3, 24 and 48 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time at a Dosing Interval (AUCtau) at Day 1 of LY3002813 in Part B and Part C
Area under the concentration versus time curve during one dosing interval at day 1 was reported.
Measured: Predose, end of infusion, 3, 24, 48 and 72 hours postdose
PK:Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of LY3002813 in Part B and C
AUCtau of LY3002813 at steady state (Day 127 [10 mg/kg Q2W] for part B and Day 141 [10 mg/kg and 20 mg/kg Q4W]) for Part C following multiple dose administration of LY3002813 was evaluated.
Measured: Part B (Day 127): predose, end of infusion, 3, 24, 48 and 72 hours postdose; Part C (Day 141): predose, end of infusion, 3, 24, 48 and 72 hours postdose
PK: Maximum Serum Concentration (Cmax) of LY3002813 at Day 1 of LY3002813
Maximum serum concentration of LY3002813 during one dosing interval at day 1 was reported.
Measured: Part A: Predose, end of infusion, 3, 24 and 48 hours postdose; Part B and C: Predose, end of infusion, 3, 24, 48 and 72 hours postdose
PK: Maximum Serum Concentration (Cmax) of LY3002813 at Steady State of LY3002813 in Part B and C
Cmax of LY3002813 at steady state (Day 127 [10 mg/kg Q2W] for part B and Day 141 [10 mg/kg and 20 mg/kg Q4W]) for Part C following multiple dose administration of LY3002813 was evaluated.
Measured: Part B (Day 127): predose, end of infusion, 3, 24, 48 and 72 hours postdose; Part C (Day 141): predose, end of infusion, 3, 24, 48 and 72 hours postdose
Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADAs) to LY3002813
Blood samples were tested to determine if a participant reacted to LY3002813 by producing anti-LY3002813 antibodies. Samples were identified as TE-ADAs if the post-treatment sample had an increase of at least 4 fold in titer from pre-treatment values. If the pre-treatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence. The percentage of participants with TE ADA was calculated as: (the number of participants with TE ADA / total number of participants with at least 1 post-treatment immunogenicity sample analyzed)*100.
Measured: Predose up to Day 589
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study start22 Dec 2015
- Primary completion28 Aug 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624778
- Sponsor's protocol ID
- 16233
- Other IDs
- I5T-MC-AACD
- Status last verified
- Jul 2024
- First submitted
- 4 Dec 2015
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gueorguieva I, Chow K, Chua L, Shcherbinin S, Zimmer JA, Evans CD, Wang H, Nery ESM, Brooks DA, Sims JR. Donanemab exposure-response in early symptomatic Alzheimer's disease. Alzheimers Dement. 2025 Jul;21(7):e70491. doi: 10.1002/alz.70491.
PubMed 40667684
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single- and Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Intravenous Doses of LY3002813 in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02624778
- Acronym / sponsor ID
- 16233
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2015 (actual)
- Primary completion
- 28 Aug 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 8 Dec 2015 (estimated)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the effect of LY3002813 on brain scans. The study will evaluate the safety of LY3002813 by looking at adverse events (side effects). The study will also look at the effect the body has on LY3002813. Study participants will have mild cognitive impairment (MCI) due to AD or mild to moderate AD.
The study involves 3 parts.
- Part A in which participants will receive a single dose of LY3002813 or placebo (no drug).
- Part B in which participants will receive multiple doses of LY3002813 or placebo for 24 weeks.
- Part C in which participants will receive multiple doses of LY3002813 or placebo for up to 72 weeks.
Drug will be given as an intravenous infusion (injection into a vein). For Parts A, B and C, the study will last approximately 72 weeks, not including screening of approximately 56 days. The study is for research purposes only and is not intended to treat any medical condition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part A: Placebo Single Dose (SD) | Placebo comparator | Drug: PlaceboParticipants received single intravenous (IV) dose of placebo. |
| Part A: 10 Milligram Per Kilogram (mg/kg) LY3002813 SD | Experimental | Biological: LY3002813Participants received single IV dose of 10 mg/kg LY3002813. |
| Part A: 20 mg/kg LY3002813 SD | Experimental | Biological: LY3002813Participants received single IV dose of 20 mg/kg LY3002813. |
| Part A: 40 mg/kg LY3002813 SD | Experimental | Biological: LY3002813Participants received single IV dose of 40 mg/kg LY3002813. |
| Part B: Placebo Q2W | Placebo comparator | Drug: PlaceboParticipants received multiple IV dose of placebo every 2 weeks (Q2W) for 24 weeks. |
| Part B: 10 mg/kg LY3002813 Q2W | Experimental | Biological: LY3002813Participants received multiple IV dose of 10 mg/kg LY3002813 Q2W for 24 weeks. |
| Part C: Placebo Q4W | Placebo comparator | Drug: PlaceboParticipants received multiple IV dose of placebo every 4 weeks (Q4W) for 72 weeks. |
| Part C:10 mg/kg LY3002813 Q4W | Experimental | Biological: LY3002813Participants received multiple IV dose of 10 mg/kg LY3002813 Q4W for 72 weeks. |
| Part C:20 mg/kg LY3002813 Q4W | Experimental | Biological: LY3002813Participants received multiple IV dose of 20 mg/kg LY3002813 Q4W for 72 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Present with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild-to-moderate AD
- Men or nonfertile women, at least 50 years of age. Nonfertile is defined as hysterectomy and/or bilateral oophorectomy, or amenorrhea for at least 1 year
- Have up to 2 partners who will provide a separate written informed consent to participate
- Have adequate vision and hearing for neuropsychological testing in the opinion of the investigator
- Positive florbetapir scan
Key exclusion criteria (9 listed)
- Do not have up to 2 reliable partners who are in frequent contact with the participant, who will accompany the participant to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications
- Are being monitored for radiation due to occupational exposure to ionized radiation, or exposure to ionizing radiation within last 12 months from an investigational study
- History of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, or stroke or epilepsy
- Have any contraindications for magnetic resonance imaging (MRI) studies, including claustrophobia, the presence of contraindicated metal (ferromagnetic) implants, cardiac pacemaker
- Have allergies to humanized monoclonal antibodies, including proteins and diphenhydramine, epinephrine, and methylprednisolone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3002813Administered IV | Biological | Part A: 10 Milligram Per Kilogram (mg/kg) LY3002813 SD, Part A: 20 mg/kg LY3002813 SD, Part A: 40 mg/kg LY3002813 SD, Part B: 10 mg/kg LY3002813 Q2W, Part C:10 mg/kg LY3002813 Q4W, Part C:20 mg/kg LY3002813 Q4W |
| PlaceboAdministered IV | Drug | Part A: Placebo Single Dose (SD), Part B: Placebo Q2W, Part C: Placebo Q4W |
Primary outcome
Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan Standard Uptake Value Ratio (SUVr)
Time frame: Baseline, Week 72
Florbetapir PET imaging was used to confirm the presence of amyloid pathology consistent with AD. Change from baseline was done to test the hypothesis that amyloid burden was reduced in participants in the treatment group. The change from baseline to the postbaseline visit of the composite summary standard uptake value ratio of florbetapir F18 was calculated. Least square (LS) mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. The composite summary measure is an unweighted average of the 6 smaller regions (anterior cingulate, frontal medial orbital, parietal, posterior cingulate, precuneus, and temporal) normalized to whole cerebellum or subject-specific white matter.
6 secondary outcomes
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)] in Part A
Time frame: Predose, end of infusion, 3, 24 and 48 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time at a Dosing Interval (AUCtau) at Day 1 of LY3002813 in Part B and Part C
Time frame: Predose, end of infusion, 3, 24, 48 and 72 hours postdose
PK:Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of LY3002813 in Part B and C
Time frame: Part B (Day 127): predose, end of infusion, 3, 24, 48 and 72 hours postdose; Part C (Day 141): predose, end of infusion, 3, 24, 48 and 72 hours postdose
PK: Maximum Serum Concentration (Cmax) of LY3002813 at Day 1 of LY3002813
Time frame: Part A: Predose, end of infusion, 3, 24 and 48 hours postdose; Part B and C: Predose, end of infusion, 3, 24, 48 and 72 hours postdose
PK: Maximum Serum Concentration (Cmax) of LY3002813 at Steady State of LY3002813 in Part B and C
Time frame: Part B (Day 127): predose, end of infusion, 3, 24, 48 and 72 hours postdose; Part C (Day 141): predose, end of infusion, 3, 24, 48 and 72 hours postdose
Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADAs) to LY3002813
Time frame: Predose up to Day 589
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40667684Gueorguieva I, Chow K, Chua L, Shcherbinin S, Zimmer JA, Evans CD, Wang H, Nery ESM, Brooks DA, Sims JR. Donanemab exposure-response in early symptomatic Alzheimer's disease. Alzheimers Dement. 2025 Jul;21(7):e70491. doi: 10.1002/alz.70491.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3002813 in people with Alzheimer Disease, run by Eli Lilly and Company at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan Standard Uptake Value Ratio (SUVr) (time frame: Baseline, Week 72). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02624778, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.