Alzheimer DiseasePhase 1NCT01837641

A Study of LY3002813 in Participants With Alzheimer's Disease

A Phase 1 study testing LY3002813-IV and LY3002813-SC in people with Alzheimer Disease, run by Eli Lilly and Company at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study will evaluate the safety of LY3002813 by looking at adverse events. The study will also look at the effect the body has on LY3002813. Study participants will be healthy or will have mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild to moderate AD. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Alzheimer Disease
What is being tested?: LY3002813-IV and LY3002813-SC
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 63 participants
Where: 6 sitesin 2 countries
Study dates: 3 May 2013to 24 Aug 2016
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy Participants:
Overtly healthy males, as determined by medical history and physical examination, willing to use a reliable method of birth control and will not donate sperm during the study
Between 18 to 40 years old.
Body Mass Index (BMI) of between 18.0 and 30.0 kilogram per meter square (kg/m^2), inclusive
Participants with Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or AD:
Present with mild cognitive impairment (MCI) due to AD or mild-to-moderate AD

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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 a caregiver/study informant who provides 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

-Healthy Participants: Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, immunological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
Participants with Mild Cognitive Impairment Due to AD or AD:
Do not have a reliable caregiver/study informant who is 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 within the past 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen post resection
All Participants:

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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
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

Trial locations and contacts

6 sites in 2 countries.

Country

City, postcode or hospital

6 sites in 2 countries

United States4 sites

Atlanta Center of Medical Research
Atlanta, Georgia, 30308
Collaborative Neuroscience Network - CNS
Long Beach, California, 90806
Compass Research
Orlando, Florida, 32806
PRAHealthSciences
Salt Lake City, Utah, 84106

Other trials in United States

Japan2 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.
Sumida-Ku, 130-0004
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.
Tokyo, 162-0053

Other trials in Japan

About this study

Official title: A Single-Dose and Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3002813 in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease

There will be seven groups of study participants. Five groups will receive a single dose of LY3002813 or placebo (no drug), followed by up to 4 multiple doses of LY3002813 or placebo given as an injection into a vein. Approximately 12 weeks will pass between the single dose and the first multiple dose. One group of participants will receive a single dose of LY3002813 given as an injection under the skin. One group of participants will receive a single dose of LY3002813 given as an injection into a vein.

Conditions: Alzheimer Disease
Being tested: LY3002813-IV, LY3002813-SC, Placebo-IV
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY3002813-IVBiological
Administered IV
LY3002813-SCBiological
Administered SC
Placebo-IVDrug
Administered IV

Study groups in NCT01837641
Study group	Role	What they receive
LY3002813-Single 0.1 mg/kg then multiple 0.3 mg/kg	Experimental	0.1 milligram per kilogram (mg/kg) single dose then 0.3 mg/kg LY3002813 given every 4 weeks for up to 16 weeks intravenously (IV) Receives: Biological: LY3002813-IV
LY3002813-Single then multiple 0.3 mg/kg	Experimental	0.3 mg/kg single dose then 0.3 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV Receives: Biological: LY3002813-IV
LY3002813-Single 1 mg/kg in Healthy Participants	Experimental	1 mg/kg single dose LY3002813 given once by IV infusion. Receives: Biological: LY3002813-IV
LY3002813-Single then multiple 1 mg/kg	Experimental	1 mg/kg single dose then 1 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV Receives: Biological: LY3002813-IV
LY3002813-Single then multiple 3 mg/kg	Experimental	3 mg/kg single dose then 3 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV Receives: Biological: LY3002813-IV
LY3002813-Single then multiple 10 mg/kg	Experimental	10 mg/kg single dose then 10 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV Receives: Biological: LY3002813-IV
Placebo-Single then multiple	Placebo comparator	Placebo given once, then every 4 weeks for up to 16 weeks IV Receives: Drug: Placebo-IV
LY3002813-SC	Experimental	Up to 3 mg/kg LY3002813 given once subcutaneously (SC) Receives: Biological: LY3002813-SC
LY3002813-IV	Experimental	Up to 3mg/kg LY3002813 given once intravenously (IV) Receives: Biological: LY3002813-IV

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Data presented are the number of participants who experienced SAEs which were considered to be related to study treatment by the investigator while on treatment and during the follow-up. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module.
Measured: Day 1 up to Day 253

Secondary outcomes (2)

Pharmacokinetics: Maximum Concentration (Cmax) of LY3002813
Maximum Concentration (Cmax) of LY3002813 after the first dose was evaluated.
Measured: Pre-dose, end of infusion for IV or 1h post injection for SC, 3, 24, 72, 96(SC), 120(SC), 144(SC), 168, 336, 504, 672, 1008, 1344, 1680 and 2016 hours (h) post-dose
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3002813
Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3002813 after the first dose was evaluated.
Measured: Pre-dose, end of infusion for IV or 1h post injection for SC, 3, 24, 72, 96(SC), 120(SC), 144(SC), 168, 336, 504, 672, 1008, 1344, 1680 and 2016h post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 May 201324 Aug 2016

First posted23 Apr 2013 (estimated)
Study start3 May 2013
Primary completion24 Aug 2016
Study completion24 Aug 2016

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.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01837641
Sponsor's protocol ID: 15082
Other IDs: I5T-MC-AACC
Status last verified: Jul 2024
First submitted: 18 Apr 2013
Last updated: 4 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose and Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3002813 in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease
ClinicalTrials.gov ID: NCT01837641
Acronym / sponsor ID: 15082
Conditions: Alzheimer Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 3 May 2013 (actual)
Primary completion: 24 Aug 2016 (actual)
Study completion: 24 Aug 2016 (actual)
First posted: 23 Apr 2013 (estimated)
Results: Posted 4 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 9

Arm	Type	Receives
LY3002813-Single 0.1 mg/kg then multiple 0.3 mg/kg	Experimental	Biological: LY3002813-IV0.1 milligram per kilogram (mg/kg) single dose then 0.3 mg/kg LY3002813 given every 4 weeks for up to 16 weeks intravenously (IV)
LY3002813-Single then multiple 0.3 mg/kg	Experimental	Biological: LY3002813-IV0.3 mg/kg single dose then 0.3 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV
LY3002813-Single 1 mg/kg in Healthy Participants	Experimental	Biological: LY3002813-IV1 mg/kg single dose LY3002813 given once by IV infusion.
LY3002813-Single then multiple 1 mg/kg	Experimental	Biological: LY3002813-IV1 mg/kg single dose then 1 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV
LY3002813-Single then multiple 3 mg/kg	Experimental	Biological: LY3002813-IV3 mg/kg single dose then 3 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV
LY3002813-Single then multiple 10 mg/kg	Experimental	Biological: LY3002813-IV10 mg/kg single dose then 10 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV
Placebo-Single then multiple	Placebo comparator	Drug: Placebo-IVPlacebo given once, then every 4 weeks for up to 16 weeks IV
LY3002813-SC	Experimental	Biological: LY3002813-SCUp to 3 mg/kg LY3002813 given once subcutaneously (SC)
LY3002813-IV	Experimental	Biological: LY3002813-IVUp to 3mg/kg LY3002813 given once intravenously (IV)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Healthy Participants:
Participants with Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or AD:

Key exclusion criteria (12 listed)

-Healthy Participants: Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, immunological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
Participants with Mild Cognitive Impairment Due to AD or AD:
All Participants:

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
LY3002813-IVAdministered IV	Biological	LY3002813-IV, LY3002813-Single 0.1 mg/kg then multiple 0.3 mg/kg, LY3002813-Single 1 mg/kg in Healthy Participants, LY3002813-Single then multiple 0.3 mg/kg, LY3002813-Single then multiple 1 mg/kg, LY3002813-Single then multiple 10 mg/kg, LY3002813-Single then multiple 3 mg/kg
LY3002813-SCAdministered SC	Biological	LY3002813-SC
Placebo-IVAdministered IV	Drug	Placebo-Single then multiple

Primary outcome

Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Day 1 up to Day 253
Data presented are the number of participants who experienced SAEs which were considered to be related to study treatment by the investigator while on treatment and during the follow-up. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module.

2 secondary outcomes

Pharmacokinetics: Maximum Concentration (Cmax) of LY3002813
Time frame: Pre-dose, end of infusion for IV or 1h post injection for SC, 3, 24, 72, 96(SC), 120(SC), 144(SC), 168, 336, 504, 672, 1008, 1344, 1680 and 2016 hours (h) post-dose
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3002813
Time frame: Pre-dose, end of infusion for IV or 1h post injection for SC, 3, 24, 72, 96(SC), 120(SC), 144(SC), 168, 336, 504, 672, 1008, 1344, 1680 and 2016h post-dose

Results and safety

Results posted to the registry on 4 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo IV	12	11
0.1 mg/kg / 0.3 mg/kg LY3002813 IV	4	4
0.3 mg/kg LY3002813 IV	7	7
1 mg/kg LY3002813 IV: Healthy Participants	6	6
1 mg/kg LY3002813 IV	9	8
3 mg/kg LY3002813 IV	11	9
10 mg/kg LY3002813 IV	6	5
3 mg/kg LY3002813 SC	8	8

Primary outcome: Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame: Day 1 up to Day 253. Count of participants. Unit: Participants

Measure	Placebo IV n = 12	0.1 mg/kg / 0.3 mg/kg LY3002813 IV n = 4	0.3 mg/kg LY3002813 IV n = 7	1 mg/kg LY3002813 IV: Healthy Participants n = 6	1 mg/kg LY3002813 IV n = 9	3 mg/kg LY3002813 IV n = 11	10 mg/kg LY3002813 IV n = 6	3 mg/kg LY3002813 SC n = 8
Value	1	0	2	0	1	0	0	0

Population analysed: All enrolled participants who received at least 1 dose of study drug.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 up to Day 253. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo IV	1 of 12 (8.3%)	8 of 12 (66.7%)	Not reported
0.1 mg/kg / 0.3 mg/kg LY3002813 IV	0 of 4 (0%)	3 of 4 (75%)	Not reported
0.3 mg/kg LY3002813 IV	2 of 7 (28.6%)	4 of 7 (57.1%)	Not reported
1 mg/kg LY3002813 IV: Healthy Participants	0 of 6 (0%)	3 of 6 (50%)	Not reported
1 mg/kg LY3002813 IV	1 of 9 (11.1%)	6 of 9 (66.7%)	Not reported
3 mg/kg LY3002813 IV	0 of 11 (0%)	7 of 11 (63.6%)	Not reported
10 mg/kg LY3002813 IV	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
3 mg/kg LY3002813 SC	0 of 8 (0%)	4 of 8 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

6 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-IV and LY3002813-SC in people with Alzheimer Disease, run by Eli Lilly and Company at 6 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 10 inclusion and 12 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 4 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 6 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 4 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?

Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Day 1 up to Day 253). 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 NCT01837641.

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 4 Oct 2024.