DIAN-TU-002

A study of a potential disease modifying treatment in individuals at risk for or with a type of early onset AD caused by a genetic mutation

Conditions

At risk of developing Alzheimer’s dementia or family history of Alzheimer's disease

Sponsor

Washington University School of Medicine

Clinical Trial

Phase III

Status

Currently recruiting

Drug

Remternetug

Countries

Germany, Spain, United Kingdom

Information about the drug that will be tested in the study

Administration

Subcutaneous injection (an injection under the skin) every 12 weeks.

Is the drug already on the market for another medical condition?

Will all participants receive the same drug?

Participants will be selected by chance to receive one of the following options:

Subcutaneous injection of remternetug
Subcutaneous injection of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect).

Neither the participant nor their doctor will know if the person is receiving the investigational drug or the placebo.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to evaluate the biomarker effect, safety and tolerability of remternetug in people at risk of developing Alzheimer’s disease (AD) who are known to have an AD-causing mutation.

How long will the treatment last?

Around 4 years
After the completion of the treatment period (remternetug/placebo), participants will enter an open-label study.

What your involvement will entail?

During the study, participants will have to undergo brain scan (PET, MRI) and lumbar punctures (CSF)
Complete tests that will assess memory and cognition

Further information on the procedures, tests and number of visits can be obtained from the study team.

Who can participate in this study?

Who can participate in the study?

To take part in the study, participants must:

Be older than 18 years
Have a genetic mutation that causes Alzheimer's disease or are a family member with a dominantly inherited Alzheimer's disease (DIAD) mutation (e.g. APP, PSEN1, PSEN2). This study is only available to people who have this rare genetic mutation that causes young onset Alzheimer's disease in their family
Have a score of 0 in the Clinical Dementia Rating-Global Score (CDR). This would suggest that the person has no impairment in his/her memory
For people of childbearing potential, must have a negative serum pregnancy test at screening, must agree not to try to become pregnant and not to breastfeed during the study and must agree to use effective contraception if partner is not sterile
Have a study partner who has a sufficient contact with the participant, is willing to participate in study procedures throughout the study duration
Agree to not donate blood or blood products for transfusion for the duration of the study.

Who cannot participate in the study?

People cannot take part in the study if they have or have experienced:

A neurologic or psychiatric disease that may currently or during the study affect cognition or the participant's ability to complete the study (i.e. severe head trauma, seizure disorder, schizophrenia, major depression)
A disease or medical condition that may interfere with the study assessments and will make the participant unsuitable for participation in or completion of the trial procedures (i.e. uncontrolled hypertension, hepatic or renal abnormalities, HIV, Hepatitis B infection, unstable or poorly controlled diabetes, morbid obesity, history of cancer)
At high risk for suicide
Drug or alcohol abuse or dependence within the past year
Evidence of significant abnormality on brain MRI scans
Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin, or body which would prevent MRI scan
History or presence of significant cardiovascular disease, liver/kidney disorders, infectious disease, immune disorder or uncontrolled hypertension
Current use of anticoagulants.

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.