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| ID | Type | Description | Link |
|---|---|---|---|
| I5T-MC-AACC | Other Identifier | Eli Lilly and Company |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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 |
|
| LY3002813-Single 1 mg/kg in Healthy Participants | Experimental | 1 mg/kg single dose LY3002813 given once by IV infusion. |
|
| 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 |
|
| 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 |
|
| LY3002813-Single then multiple 10 mg/kg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3002813-IV | Biological | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 up to Day 253 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3002813 | Maximum Concentration (Cmax) of LY3002813 after the first dose was evaluated. | 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 |
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Inclusion Criteria:
Healthy Participants:
Participants with Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or AD:
Exclusion Criteria:
-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:
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Network - CNS | Long Beach | California | 90806 | United States | ||
| Compass Research |
Dose-escalation study in participants(pts) with mild cognitive impairment (MCI) due to Alzheimer's disease (AD).Under an amendment,Pharmacokinetics of unblinded single IV dose of 1 milligram per kilogram (mg/kg) LY3002813 in young,healthy male pts was assessed if absence of amyloid target affected the PK as compared to amyloid-positive pts with AD.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo IV | Single dose of placebo matching LY3002813 given once, then every 4 weeks for up to 16 weeks by intravenous (IV) infusion. |
| FG001 | 0.1 mg/kg / 0.3 mg/kg LY3002813 IV | Single dose of 0.1 milligram per kilogram (mg/kg) LY3002813 given once, then 0.3 mg/kg LY3002813 every 4 weeks for up to 16 weeks by IV infusion. |
| FG002 | 0.3 mg/kg LY3002813 IV | Single dose of 0.3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion. |
| FG003 | 1 mg/kg LY3002813 IV: Healthy Participants | Single dose of 1 mg/kg LY3002813 given once by IV infusion. |
| FG004 | 1 mg/kg LY3002813 IV | Single dose of 1 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion. |
| FG005 | 3 mg/kg LY3002813 IV | Single dose of 3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion. |
| FG006 | 10 mg/kg LY3002813 IV | Single dose of 10 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion. |
| FG007 | 3 mg/kg LY3002813 SC | Single dose of 3 mg/kg LY3002813 given once subcutaneously (SC). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo IV | Single dose of placebo matching LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion. |
| BG001 | 0.1 mg/kg / 0.3 mg/kg LY3002813 IV | Single dose of 0.1 mg/kg LY3002813 given once, then 0.3 mg/kg LY3002813 every 4 weeks for up to 16 weeks by IV infusion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Day 1 up to Day 253 |
|
Day 1 up to Day 253
All enrolled participants who received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo IV | Single dose of placebo matching LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-cardiac chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Experimental |
10 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 | Placebo given once, then every 4 weeks for up to 16 weeks IV |
|
| LY3002813-SC | Experimental | Up to 3 mg/kg LY3002813 given once subcutaneously (SC) |
|
| LY3002813-IV | Experimental | Up to 3mg/kg LY3002813 given once intravenously (IV) |
|
| LY3002813-SC | Biological | Administered SC |
|
| Placebo-IV | Drug | Administered IV |
|
Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3002813 after the first dose was evaluated. |
| 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 |
| Orlando |
| Florida |
| 32806 |
| United States |
| Atlanta Center of Medical Research | Atlanta | Georgia | 30308 | United States |
| PRAHealthSciences | Salt Lake City | Utah | 84106 | United States |
| 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 | Japan |
| 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 | Japan |
| Adverse Event |
|
| Withdrawal by Subject |
|
| BG002 | 0.3 mg/kg LY3002813 IV | Single dose of 0.3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion. |
| BG003 | 1 mg/kg LY3002813 IV: Healthy Participants | Single dose of 1 mg/kg LY3002813 given once by IV infusion. |
| BG004 | 1 mg/kg LY3002813 IV | Single dose of 1 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion. |
| BG005 | 3 mg/kg LY3002813 IV | Single dose of 3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion. |
| BG006 | 10 mg/kg LY3002813 IV | Single dose of 10 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion. |
| BG007 | 3 mg/kg LY3002813 SC | Single dose of 3 mg/kg LY3002813 given once SC. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| 0.1 mg/kg / 0.3 mg/kg LY3002813 IV |
Single dose of 0.1 mg/kg LY3002813 given once, then 0.3 mg/kg LY3002813 every 4 weeks for up to 16 weeks by IV infusion. |
| OG002 | 0.3 mg/kg LY3002813 IV | Single dose of 0.3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion. |
| OG003 | 1 mg/kg LY3002813 IV: Healthy Participants | Single dose of 1 mg/kg LY3002813 given once by IV infusion. |
| OG004 | 1 mg/kg LY3002813 IV | Single dose of 1 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion. |
| OG005 | 3 mg/kg LY3002813 IV | Single dose of 3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion. |
| OG006 | 10 mg/kg LY3002813 IV | Single dose of 10 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion. |
| OG007 | 3 mg/kg LY3002813 SC | Single dose of 3 mg/kg LY3002813 given once SC. |
|
|
| Secondary | Pharmacokinetics: Maximum Concentration (Cmax) of LY3002813 | Maximum Concentration (Cmax) of LY3002813 after the first dose was evaluated. | All enrolled participants who received at least 1 dose of study drug and have evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (μg/mL) | 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 |
|
|
|
| Secondary | 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. | All enrolled participants who received at least 1 dose of study drug and have evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*day per milliliter (μg*day/mL) | 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 |
|
|
|
| 1 |
| 12 |
| 8 |
| 12 |
| EG001 | 0.1 mg/kg / 0.3 mg/kg LY3002813 IV | Single dose of 0.1 mg/kg LY3002813 given once, then 0.3 mg/kg LY3002813 every 4 weeks for up to 16 weeks by IV infusion. | 0 | 4 | 3 | 4 |
| EG002 | 0.3 mg/kg LY3002813 IV | Single dose of 0.3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion. | 2 | 7 | 4 | 7 |
| EG003 | 1 mg/kg LY3002813 IV: Healthy Participants | Single dose of 1 mg/kg LY3002813 given once by IV infusion. | 0 | 6 | 3 | 6 |
| EG004 | 1 mg/kg LY3002813 IV | Single dose of 1 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion. | 1 | 9 | 6 | 9 |
| EG005 | 3 mg/kg LY3002813 IV | Single dose of 3 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion. | 0 | 11 | 7 | 11 |
| EG006 | 10 mg/kg LY3002813 IV | Single dose of 10 mg/kg LY3002813 given once, then every 4 weeks for up to 16 weeks by IV infusion. | 0 | 6 | 2 | 6 |
| EG007 | 3 mg/kg LY3002813 SC | Single dose of 3 mg/kg LY3002813 given once SC. | 0 | 8 | 4 | 8 |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oral lichen planus | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Electrocardiogram abnormal | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cerebral microhaemorrhage | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Parkinsonism | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Apathy | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Intentional self-injury | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Persecutory delusion | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Allergic sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Micrographic skin surgery | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Skin neoplasm excision | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Ischaemia | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |