Study on the Safety and Effects of LY3372689 in Patients with Early Alzheimer’s Disease

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What is this study about?

This clinical trial is focused on studying Alzheimer’s Disease, a condition that affects memory and thinking skills. The study will evaluate a new treatment called LY3372689, which is taken as a tablet. The purpose of the study is to assess the safety, tolerability, and effectiveness of LY3372689 in people with early symptoms of Alzheimer’s Disease. Participants will be randomly assigned to receive either the new treatment or a placebo, which looks like the treatment but does not contain the active substance.

Another part of the study involves using a substance called Flortaucipir, which is given as an injection. This substance helps in imaging techniques to detect certain changes in the brain associated with Alzheimer’s Disease. The study will last for a period of time, during which participants will have regular check-ups and assessments to monitor their condition and any changes in their symptoms.

The study aims to understand how LY3372689 affects the progression of Alzheimer’s Disease by comparing it to the placebo. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and to gather important information about the treatment’s impact on their health and well-being.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including a gradual change in memory function over at least six months, a Mini-Mental State Examination (MMSE) score between 22 and 30, and a Clinical Dementia Rating (CDR) global score between 0.5 and 1.0.

A study partner must provide written consent to participate.

2 baseline assessment

Initial assessments are conducted to establish a baseline. This includes a positron emission tomography (PET) scan using flortaucipir (18f) to confirm moderate levels of tau pathology in the brain.

3 medication administration

Participants receive either the investigational drug LY3372689 or a placebo. Both are administered in tablet form for oral use.

The specific dosage and frequency of administration are determined by the study protocol.

4 ongoing assessments

Throughout the study, regular assessments are conducted to monitor safety, tolerability, and the effect of the medication on Alzheimer’s disease progression.

These assessments include clinical evaluations and may involve additional PET scans.

5 end of study evaluation

At the end of the study, a final evaluation is conducted to assess changes from the baseline using the Integrated Alzheimer’s Disease Rating Scale (iADRS).

The study aims to determine the effect of LY3372689 compared to the placebo on the progression of Alzheimer’s disease.

Who Can Join the Study?

Participants must have a gradual and progressive change in memory function that has been noticed by themselves or someone close to them for at least 6 months.
Participants need to have a Mini-Mental State Examination (MMSE) score between 22 and 30. This is a test that helps measure memory and thinking abilities.
Participants should have a Clinical Dementia Rating (CDR) global score between 0.5 and 1.0, with a memory box score of at least 0.5. This is another way to assess memory and thinking skills.
Participants must meet specific criteria on a positron emission tomography (PET) scan using a substance called 18F flortaucipir. This scan helps to see certain changes in the brain.
Participants need to have a study partner who agrees to join the study and provide written consent. This person will help provide information about the participant’s condition.

Who Cannot Join the Study?

Participants who do not have early symptoms of Alzheimer’s disease.
Participants who do not have moderate levels of tau pathology. Tau pathology refers to changes in the brain related to a protein called tau, which is often found in Alzheimer’s disease.
Participants who are not within the specified age range for the study.
Participants who belong to a group that is not included in the study.
Participants who are not male or female, as both genders are included in the study.
Participants who are considered part of a vulnerable population that is not eligible for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Diamond Clinic Sp. z o.o.	Cracow	Poland
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy	Poznan	Poland

Other Sites

Site Name	City	Country
Centrum Medyczne Neuromed Sp. z o.o.	Bydgoszcz	Poland
Centrum Medyczne Senior	Sopot	Poland
Euromedis Sp. z o.o.	Szczecin	Poland
Centrum Medyczne Neuro Protect	Warsaw	Poland
Wrocławskie Centrum Alzheimerowskie	Wroclaw	Poland
Pnwznnaaf Ccfpibg Pjggfksunbnzoss	Bialystok	Poland
Cxlgosc Bsqgr Kpqnqpxjvfa Pkmcufty Swc z ofcj	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	08.12.2021

Trial locations

Investigated drugs:

LY3372689 is an investigational medication being studied for its potential effects on Alzheimer’s disease. The trial aims to evaluate the safety, tolerability, and efficacy of this medication in individuals who are in the early stages of Alzheimer’s and have moderate levels of tau pathology, which is a characteristic feature of the disease. The goal is to see if LY3372689 can slow down the progression of symptoms associated with Alzheimer’s disease.

Investigated diseases:

Dementia Alzheimer's type

Alzheimer Disease – Alzheimer’s disease is a progressive neurological disorder that leads to the degeneration of brain cells, causing memory loss and cognitive decline. It typically begins with mild memory lapses and confusion, which gradually worsen over time. As the disease progresses, individuals may experience difficulties with language, disorientation, mood swings, and behavioral changes. In advanced stages, individuals may lose the ability to carry out daily activities and require full-time care. The disease is associated with the accumulation of proteins in the brain, such as amyloid plaques and tau tangles, which disrupt normal brain function. Alzheimer’s disease is the most common cause of dementia among older adults.

Trial ID:

2024-512295-36-00

Protocol code:

I9X-MC-MTAE

NCT ID:

NCT05063539

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effects of LY3372689 in Patients with Early Alzheimer’s Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?