臨床研究等提出・公開システム

A Randomized, Double-Blinded Study to Evaluate the Efficacy and Safety of Mevidalen in Patients With Alzheimer's Disease (I7S-MC-HBEO)

A Study of Mevidalen (LY3154207) in Participants With Alzheimer's Disease (I7S-MC-HBEO)

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Recruiting

Nov. 08, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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.

- 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.

Both

Alzheimer Disease

DRUG: Mevidalen(Other Name: LY3154207)
Administered orally
DRUG: Placebo
Administered orally

[Study Arms]
Experimental: Mevidalen (high dose)
Mevidalen high dose administered orally.
Interventions:
Drug: Mevidalen
Experimental: Mevidalen (low dose)
Mevidalen low dose administered orally.
Interventions:
Drug: Mevidalen
Placebo Comparator: Placebo
Placebo administered orally.
Interventions:
Drug: Placebo

Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) [ Time Frame: Baseline, Week 24
iADRS assesses the impact of cognitive loss on everyday activities and provides a measure of global AD severity as a single summary score. It comprises of 2 underlying domains "cognitive ability" and "functional ability," and integrates the items in both the domains a single overall score ranging from 0 to 144, with lower scores indicating worse performance.

+81-3-6779-8166

No

United States