A Study of LY4006895 in Healthy Participants With Early Symptomatic Alzheimer's Disease (AD)
NCT ID: NCT06657768
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
88 participants
INTERVENTIONAL
2024-10-29
2027-07-31
Brief Summary
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Blood tests will be performed to check how much LY4006895 gets into the bloodstream and how long it takes the body to eliminate it.
This is a 2-part study and will last approximately 29 weeks for Part A and 61 weeks for Part B, including a screening period for each part.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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LY4006895 of Part A (SAD)
Single-ascending doses of LY4006895 administered intravenously (IV)
LY4006895
Administered IV
Placebo Part A
Placebo administered IV
Placebo
Administered IV
LY4006895 of Part B (MAD)
Multiple-ascending doses of LY4006895 will be administered IV
LY4006895
Administered IV
Placebo Part B
Placebo administered IV
Placebo
Administered IV
Interventions
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LY4006895
Administered IV
Placebo
Administered IV
Eligibility Criteria
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Inclusion Criteria
* Have a body mass index (BMI) within the range 18 to 40 kilogram per square meter (kg/m²)
For Part A:
* Have early symptomatic AD, as defined by:
* Gradual and progressive change in memory function for at least 6 months, as reported by the participant or informant
* A Mini-Mental State Exam (MMSE) score of 18 to 30 at screening
* A Clinical Dementia Rating (CDR) global score of 0.5 to 1.0 (inclusive), with a memory box score greater than or equal to 0.5 at screening
For Part B:
* Have up to 2 reliable study partners who are in frequent contact with the participant (defined as at least 10 hours per week), one of whom at any one occasion: will accompany the participant to the study visits, will be available by telephone at designated times, and will provide a separate written informed consent to participate
Exclusion Criteria
* Have screening hemoglobin (Hb) less than 12 grams per deciliter (g/dL) or evidence of iron-deficiency (ferritin less than 30 nanograms per milliliter (ng/mL), or presence/history of hemoglobinopathy
* Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening that cannot be explained by regular concomitant medications
* Have previous exposure to any anti-tau therapy
* Are pregnant or intend to become pregnant or to breastfeed during the study
For Part B:
* Have a current exposure to an amyloid targeted therapy. Prior exposure to amyloid targeted therapies greater than 1 year from the last dose may be permitted at the discretion of the investigator and in consultation with the sponsor. A listing of amyloid targeted therapies will be provided
* Have a sensitivity to florataucipir 18F
* Have contraindication to magnetic resonance imaging (MRI) including claustrophobia or the presence of contraindicated metal (ferrogmagnetic) implants/cardiac pacemaker
45 Years
85 Years
ALL
Yes
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Collaborative Neuroscience Network - CNS
Los Alamitos, California, United States
K2 Medical Research - The Villages
Lady Lake, Florida, United States
K2 Medical Research
Maitland, Florida, United States
Atlanta Center of Medical Research
Atlanta, Georgia, United States
CenExel iResearch, LLC (CenExel iRA)
Decatur, Georgia, United States
CenExel-HRI
Marlton, New Jersey, United States
Duke Early Phase Research Unit
Durham, North Carolina, United States
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
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J5K-MC-OQAA
Identifier Type: OTHER
Identifier Source: secondary_id
27263
Identifier Type: -
Identifier Source: org_study_id
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