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New treatment option for Alzheimer Disease
Official title A Study of LY4006895 in Healthy Participants With Early Symptomatic Alzheimer's Disease (AD)
ClinicalTrials.gov ID: NCT06657768
What this study is testing
What is LY4006895?
LY4006895 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for alzheimer disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY4006895. Part A will administer a single-ascending dose in healthy participants or Part B will administer multiple-ascending doses in participants with early symptomatic Alzheimer's Disease (AD).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 85. Healthy volunteers may be eligible.
You may be able to join if
- for Part A and Part B: \- Have a body mass index (BMI) within the range 18 to 40 kilogram per square meter (kg/m²) For Part A:
- Are overtly healthy as determined by medical evaluation. Rescreening is not allowed in this study For Part B:
- 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
You likely can't join if
- for Part A and Part B:
- Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, neurologic (MAD...
- Have screening hemoglobin (Hb) less than 12 grams per deciliter (g/dL) or evidence of iron-deficiency (ferritin less than 30 nanograms per milliliter...
- 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
See the full eligibility criteria
- for Part A and Part B: \- Have a body mass index (BMI) within the range 18 to 40 kilogram per square meter (kg/m²) For Part A:
- Are overtly healthy as determined by medical evaluation. Rescreening is not allowed in this study For Part B:
- 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
- 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...
- for Part A and Part B:
- Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, neurologic (MAD: other than AD), psychiatric, immunologic, or hematologic disease and...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Alamitos, California, United States
- Lady Lake, Florida, United States
- Maitland, Florida, United States
- Naples, Florida, United States
- Port Orange, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Decatur, Georgia, United States
- Farmington Hills, Michigan, United States
- Marlton, New Jersey, United States
- Durham, North Carolina, United States
- Bunkyō City, Japan
- Ōbu, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Alamitos, California, United States; Lady Lake, Florida, United States; Maitland, Florida, United States; Naples, Florida, United States; Port Orange, Florida, United States; Tampa, Florida, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.