Alzheimer DiseasePhase 1NCT06657768
A Study of LY4006895 in Healthy Participants With Early Symptomatic Alzheimer's Disease (AD)
A Phase 1 study testing LY4006895 in people with Alzheimer Disease and Healthy, run by Eli Lilly and Company at 13 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Healthy
- What is being tested?
- LY4006895
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 29 Oct 2024to Jul 2027
- Phase
- Phase 1
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 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
13 sites in 2 countries
United States11 sites, 11 recruiting
- Recruiting
Atlanta Center of Medical Research
Atlanta, Georgia, 30331
404-881-5800
Elyssa Barron
- Recruiting
CenExel iResearch, LLC (CenExel iRA)
Decatur, Georgia, 30030
404-537-1281
Kimball Johnson
- Not yet recruiting
Duke Early Phase Research Unit
Durham, North Carolina, 27710
919-684-5196
Shruti Raja
- Not yet recruiting
QUEST Research Institute
Farmington Hills, Michigan, 48334
248-957-8940
Aaron Ellenbogen
- Recruiting
K2 Medical Research - The Villages
Lady Lake, Florida, 32159
321-278-5590
Craig Curtis
- Recruiting
Collaborative Neuroscience Network - CNS
Los Alamitos, California, 90720
8667874257 or 5627427116
Steven Reynolds
- Recruiting
K2 Medical Research
Maitland, Florida, 32751
407-500-5252
Brandon Lenox
- Recruiting
CenExel-HRI
Marlton, New Jersey, 08053
856-452-9901
Elan Cohen
- Not yet recruiting
Aqualane Clinical Research
Naples, Florida, 34105
239-529-6780
William Justiz
- Not yet recruiting
Progressive Medical Research
Port Orange, Florida, 32127
386-304-7070
Alexander White
- Not yet recruiting
K2 Medical Research - Tampa
Tampa, Florida, 33634
813-800-5252
Kelley Wilson
Japan2 sites, 2 recruiting
- Not yet recruiting
The University of Tokyo Hospital
Bunkyō City, 113-8654
81120023812
Yoshiki Niimi
- Not yet recruiting
National Center for Geriatrics and Gerontology
Ōbu, 4748511
81120023812
Keisuke Suzuki
About this study
Official title: A Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, PK and PD of LY4006895 in Healthy Volunteers and Patients With Early Symptomatic AD
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.
- Conditions
- Alzheimer Disease, Healthy
- Being tested
- LY4006895, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4006895Drug
Administered IV
PlaceboDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY4006895 of Part A (SAD) | Experimental | Single-ascending doses of LY4006895 administered intravenously (IV) Receives: Drug: LY4006895 |
| Placebo Part A | Placebo comparator | Placebo administered IV Receives: Drug: Placebo |
| LY4006895 of Part B (MAD) | Experimental | Multiple-ascending doses of LY4006895 will be administered IV Receives: Drug: LY4006895 |
| Placebo Part B | Placebo comparator | Placebo administered IV Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Discontinuations due to Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline to Study Completion (Up to 61 Weeks)
Secondary outcomes (2)
PK: Maximum Concentration (Cmax) of LY4006895
PK: Cmax of LY4006895
Measured: Baseline to Study Completion (Up to 61 Weeks)
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4006895
PK: AUC of LY4006895
Measured: Baseline to Study Completion (Up to 61 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start29 Oct 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657768
- Sponsor's protocol ID
- 27263
- Other IDs
- J5K-MC-OQAA
- Status last verified
- Jun 2026
- First submitted
- 23 Oct 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No