325 Participants NeededMy employer runs this trial

ALZ-801 for Alzheimer's Disease

(APOLLOE4 Trial)

Recruiting at 7 trial locations

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test the safety and effectiveness of a new treatment called ALZ-801 for people in the early stages of Alzheimer's disease with a specific genetic profile (APOE4/4). Participants will receive either ALZ-801 or a placebo (a dummy pill) at random to compare outcomes. This study suits those with mild memory problems who have experienced memory loss over the past year. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for Alzheimer's.

Will I have to stop taking my current medications?

The trial requires that you have not taken memantine for at least 12 weeks before starting. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that ALZ-801 is likely to be safe for humans?

Research has shown that ALZ-801 is generally safe for people. Studies have found it to be well-tolerated, especially in individuals with early Alzheimer's who possess the APOE4/4 gene type. Common side effects, such as nausea and vomiting, are usually mild to moderate. Taking ALZ-801 with food can help reduce stomach issues. The risk of serious brain-related side effects, known as ARIA, remains low. Overall, evidence suggests that ALZ-801 is a safe option for those considering this treatment.12345

Why do researchers think this study treatment might be promising for Alzheimer's?

ALZ-801 is unique because it targets Alzheimer's disease by stabilizing the amyloid-beta protein in the brain, which is thought to play a key role in the development of the condition. Unlike standard treatments such as donepezil or memantine that primarily manage symptoms, ALZ-801 aims to address the underlying cause of the disease. Researchers are excited about this treatment because it could potentially modify the disease process itself, offering hope for a more effective approach to slowing or halting the progression of Alzheimer's.

What evidence suggests that ALZ-801 might be an effective treatment for Alzheimer's?

Research has shown that ALZ-801, which participants in this trial may receive, may help treat Alzheimer's disease, particularly in individuals with the APOE4/4 gene type. Early results suggest that ALZ-801 can lower amyloid levels in the brain, which are protein buildups linked to Alzheimer's. Studies have found that reducing these amyloid levels can slow down memory and thinking problems. ALZ-801 prevents amyloid proteins from clumping together in the brain, which might help maintain brain function and delay the worsening of Alzheimer's symptoms.678910

Are You a Good Fit for This Trial?

This trial is for people with early Alzheimer's disease who have two copies of the APOE4 gene. They should show memory loss over the past year and have specific scores on cognitive tests like MMSE and CDR. People can't join if they've had recent strokes, seizures (except childhood febrile seizures), other brain disorders, major depression in the last year, or are taking certain dementia medications.

Inclusion Criteria

Do you have a family member, friend, or caregiver who spends at least 8 hours per week with you and would be willing to participate in the study alongside you?
Have you been formally diagnosed with Alzheimer's Disease?
Over the past year, have you or someone close to you noticed that your memory seems worse than before?
See 3 more

Exclusion Criteria

Do you have any other serious medical conditions that could make it more dangerous for you to participate in a trial?

Timeline

Screening

Participants are evaluated to confirm eligibility

Up to 4 weeks

Treatment

Participants receive the study treatment

14 weeks
Includes regular clinic visits and assessments

Follow-up

Participants are monitored for safety

4 weeks