A Study of Mevidalen (LY3154207) in Participants With Alzheimer's Disease

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Alzheimer Disease

Treatments: Drug: Placebo; Drug: Mevidalen

Study type: Interventional

Funder types: Industry

Identifiers

NCT06538116

18822

I7S-MC-HBEO (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to look at how safe the study drug (mevidalen) is and whether it works to alleviate symptoms when given to people with mild to moderate Alzheimer Disease (AD) dementia. This is done by looking at participants: thinking and memory (cognition), everyday activities and sleep, AD symptoms, physical activity, irritability or anxiety. The study is expected to last approximately 26 weeks and may include up to 14 visits.

Enrollment: 300 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have gradual and progressive decline in memory function for greater than or equal to 6 months that is severe enough to interfere with activities of daily living.
• Have MMSE score of 13 to 24.
• Have eligibile plasma P-tau or historical evidence of AD pathology.
• Have a reliable study partner who will provide written informed consent to participate, is in frequent contact with the participant and will be available at designated times.
• Males with partners of childbearing potential must agree to abide with provided contraception guidance.

Exclusion criteria

• Are individuals of childbearing potential.
• Have significant central nervous system or psychiatric disease, other than AD, that in the investigator's opinion may affect cognition or the ability to complete the study (e.g: head trauma, stroke, seizure disorder etc.,).
• Have cardiovascular-related risk factors or history that include uncontrolled hypertension, heart failure, stroke; or liver-related abnormalities.
• Use of moderate or strong CYP3A4 inhibitors or inducers.
• Have participated within the last 30 days in a clinical trial involving an investigational product.
• Participant is, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups, including a placebo group

Mevidalen (high dose)

Experimental group

Description:

Mevidalen high dose administered orally.

Treatment:

Drug: Mevidalen

Mevidalen (low dose)

Experimental group

Description:

Mevidalen low dose administered orally.

Treatment:

Drug: Mevidalen

Placebo

Placebo Comparator group

Description:

Placebo administered orally.

Treatment:

Drug: Placebo