A Study of LY4006895 in Healthy Participants With Early Symptomatic Alzheimer's Disease (AD)
Recruiting
Phase 1Interventional Study
Alzheimer DiseaseHealthy
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
45 – 85
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
128 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for
This trial is looking for healthy adults and participants with early symptoms of Alzheimer's disease. Those who join will take a study drug called LY4006895 and undergo various health checks over several months.
Are You a Good Fit for This Trial?
You may be able to join if
I have a body mass index (BMI) between 18 and 40.
I am overtly healthy as confirmed by a medical evaluation.
I have early symptoms of Alzheimer's disease.
I have had changes in my memory for at least 6 months.
I have a Mini-Mental State Exam (MMSE) score between 18 and 30.
I have a Clinical Dementia Rating (CDR) score of 0.5 to 1.0.
I have up to 2 reliable study partners who support me.
I can complete the study visits with my study partners.
You may not be able to join if
I have a serious or unstable illness.
My hemoglobin level is less than 12 grams per deciliter.
I have a history of being actively suicidal.
I regularly use drugs of abuse.
I have previously taken anti-tau therapy.
I am pregnant or plan to become pregnant or breastfeed.
I am currently taking an amyloid targeted therapy.
I have a sensitivity to florataucipir 18F.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Blood tests will be performed to check how much LY4006895 gets into the bloodstream and how long it …
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).
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.
Trial Locations
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Eligibility Criteria
Inclusion 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 defin…
Inclusion 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 available by telephone at designated times, and will provide a separate written informed consent to participate
Exclusion Criteria 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 other conditions that, in the investigator's opinion, could interfere with the participant's ability to complete the study; or has a life expectancy of less than 24 months
* 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
Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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