Dementia Support Line
A study to test DNL628 in people with early Alzheimer's disease
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The Clinical Trial Finder is for information only. To join a clinical trial you must meet the eligibility criteria set by the study and the research team will discuss this with you.
Trial description
Tau is a protein which helps support brain cells. However, in Alzheimer’s disease, too much tau can clump together and cause damage which may lead to memory and thinking problems. This study is testing a new medicine called DNL628. This medicine may lower the amount of tau which may help slow the disease.
What is the aim of the study?
In this research study involving people with Alzheimer’s disease, we will be testing:
- if the study drug is safe and well tolerated
- how much of the study drug people can safely receive
- how the body processes the study drug
- how much the study drug reaches the brain, and whether it changes the tau protein levels
- how memory, thinking and brain scans may change with treatment.
What will participants be asked to do during the study?
During the study, participants will:
- have a physical and neurological examination, including recording your height and weight
- have some laboratory tests, such as blood or urine. These tests help doctors check for any new side effects, such as symptoms or health changes that might happen after receiving the study medicine
- complete tests that look at memory, thinking, and emotional wellbeing
- have brain scans called PET scans and magnetic resonance imaging (MRI) scans. These scans take detailed pictures of the brain to help doctors check brain health and safety.
Eligibility criteria
People may be able to take part if they have:
- a BMI ≥18-<32 kg/m2 and body weight of ≥45 kg
- a diagnosis of Alzheimer’s disease
- supportive evidence of amyloid plaques either with historical records or laboratory testing at screening
- Alzheimer’s disease severity as defined by:
o A Clinical Dementia Rating global score of 0.5 or 1
o A Mini-Mental State Examination score of 20 to 30 (inclusive) - a study partner (a close friend or family member who spends at least 10 hours per week with you and can provide information at study visits).
People may not be able to take part if they have:
- a clinically significant disease affecting the brain other than Alzheimer’s disease
- a serious illness that can affect participation in all required study visits and assessments
- had previous exposure to anti-amyloid therapy
- had previous exposure to gene therapy.
If you're not sure if you can take part in this study but would like to, please contact us by making an enquiry. A member of the research team will talk with you and help find out if the study is right for you.
Clinical trial team
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Recruitment start
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Eligibility criteria
People may be able to take part if they have:
- a BMI ≥18-<32 kg/m2 and body weight of ≥45 kg
- a diagnosis of Alzheimer’s disease
- supportive evidence of amyloid plaques either with historical records or laboratory testing at screening
- Alzheimer’s disease severity as defined by:
o A Clinical Dementia Rating global score of 0.5 or 1
o A Mini-Mental State Examination score of 20 to 30 (inclusive) - a study partner (a close friend or family member who spends at least 10 hours per week with you and can provide information at study visits).
People may not be able to take part if they have:
- a clinically significant disease affecting the brain other than Alzheimer’s disease
- a serious illness that can affect participation in all required study visits and assessments
- had previous exposure to anti-amyloid therapy
- had previous exposure to gene therapy.
If you're not sure if you can take part in this study but would like to, please contact us by making an enquiry. A member of the research team will talk with you and help find out if the study is right for you.