Active not recruitingPHASE2INTERVENTIONAL

A Study to Evaluate Efficacy and Safety of Intravenous Sabirnetug in Participants With Early Alzheimer's Disease (ALTITUDE-AD)

The ALTITUDE-AD study is looking into a new treatment called sabirnetug for people in the early stages of Alzheimer's disease. The main goal is to find out if sabirnetug, given as an infusion every four weeks, can help slow down the decline in memory and daily function compared to a dummy medicine (placebo). This is a Phase 2 study, meaning researchers are still checking if the treatment is effective and safe. They will be carefully monitoring participants aged 50 to 90 years, including those taking existing Alzheimer's medications, to understand how sabirnetug works and if it can offer a new way to manage early Alzheimer's.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Acumen Pharmaceuticals

Enrolment target

542

Start

29 Feb 2024

Estimated completion

01 Oct 2026

Alzheimer Disease

What is this study about?

This research study, called ALTITUDE-AD, is focused on finding new ways to help people with early Alzheimer's disease. Alzheimer's affects memory, thinking, and daily activities, and researchers are constantly looking for new treatments to slow its progression.

In this study, they are testing a new medicine called sabirnetug. The main idea is to see if sabirnetug can slow down the changes in memory and thinking that happen with early Alzheimer's. To do this, some people will receive sabirnetug through an infusion (like a drip) every four weeks, while others will receive a 'placebo' – a dummy medicine that looks just like sabirnetug but contains no active drug. This allows the researchers to fairly compare the effects of sabirnetug against not receiving the active treatment.

This is a 'Phase 2' study, which means it's an important step in developing new medicines. At this stage, researchers are trying to learn more about how well the medicine works, what the right dose might be, and if it has any side effects. The information gathered from this study will help decide if sabirnetug should be tested in larger studies in the future, potentially bringing us closer to new treatment options for Alzheimer's disease.

Key takeaways

This study is for people with early Alzheimer's disease.
It tests a new medicine called sabirnetug to slow memory decline.
You would receive sabirnetug or a dummy medicine via infusion every four weeks.
The study includes regular check-ups, memory tests, and possibly brain scans.
A supportive study partner is required.
You can stop participating at any time.

Who may be eligible?

This study is open to both men and women between the ages of 50 and 90 years old. To be considered, you must have an early form of Alzheimer's disease, either a mild memory problem due to Alzheimer's or probable Alzheimer's. Your memory and thinking skills will be checked with certain tests, and you'll need to show signs of a specific protein in your brain linked to Alzheimer's, either through a brain scan or a spinal fluid test.

There are also some physical requirements, like weighing between about 4.5 and 25 stone (30 to 160 kilograms). If you're currently taking medicines for Alzheimer's symptoms, like cholinesterase inhibitors or memantine, you would need to have been on a steady dose for at least three months before starting the study. It's also important to have a reliable study partner or caregiver who can help you throughout the study.

However, some things would prevent you from taking part. For example, if you can't have an MRI scan (due to things like claustrophobia or certain metal implants), or if a brain scan shows other serious issues. You also wouldn't be able to join if you have other serious brain conditions, like certain types of dementia, a past stroke, or Parkinson's disease, or other significant ongoing health problems.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 50 and 90 years old?
Have you been diagnosed with early Alzheimer's disease or mild memory problems due to Alzheimer's?
Do you have a reliable friend or family member who can be your study partner?
Are you able to have MRI scans?
If you take Alzheimer's medication, has your dose been stable for at least 3 months?
Do you not have other serious brain conditions like a past stroke or Parkinson's disease?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the new medicine, sabirnetug, or a placebo (a dummy medicine). You won't know which one you are receiving, and neither will the study team, to ensure the results are fair. Both medicines will be given as an infusion into a vein once every four weeks.

Throughout the study, you'll have regular hospital visits for various assessments. These will include blood tests, memory and thinking tests, and possibly brain scans (MRIs) to monitor your brain health. You'll also be regularly checked for any side effects and to see how your body is responding to the treatment. Your study partner will also be involved in some of these assessments. The total duration of the study, including follow-up, will be explained fully by the study team, but typically clinical trials involve multiple visits over many months.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new experimental treatment before it's widely available and contributing to medical research that could help others in the future. However, there are also potential risks; the new medicine might have side effects that are not yet fully known, or it might not work for you. The study procedures themselves, like blood tests or scans, also carry minor risks. It's crucial to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (68)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Neurology Center of Southern California - Carlsbad
Verified postcode
Carlsbad, United States
Neurology Center of North Orange County
Verified postcode
Fullerton, United States
Irvine Medical Research
Verified postcode
Irvine, United States
Healthy Brain Research
Verified postcode
Long Beach, United States
Syrentis Clinical Research
Verified postcode
Santa Ana, United States
CenExel - California Neuroscience Research Medical Group, Inc (CNR)
Verified postcode
Sherman Oaks, United States
Research Center for Clinical Studies, LLC
Verified postcode
Norwalk, United States
Re:Cognition Health - Fairfax
Verified postcode
Washington D.C., United States
JEM Research Institute
Verified postcode
Atlantis, United States
Bradenton Research Center
Verified postcode
Bradenton, United States
Gil Fernandez-Yera, MD, PA
Verified postcode
Coral Gables, United States
Brain Matters Research
Verified postcode
Delray Beach, United States

Common questions

What is sabirnetug?

Sabirnetug is a new medicine being tested to see if it can help slow down the progression of early Alzheimer's disease.

What is a placebo?

A placebo is a dummy medicine that looks exactly like the real treatment but contains no active drug. It helps researchers compare the true effects of the new medicine.

How will I receive the medicine?

The medicine (or placebo) will be given to you as an infusion, similar to a drip, once every four weeks.

Why do I need a study partner?

A study partner helps provide important information about your memory and daily activities, which is vital for the researchers to understand your progress.

Can I continue my current Alzheimer's medication?

Yes, if you're on stable doses of certain Alzheimer's medications, you can usually continue them throughout the study.