Dementia Support Line
Study to evaluate ALN-5288 in patients with Alzheimer's disease
Contact
Use the information below to reference this clinical trial when speaking with your healthcare professional or research team.
Note: the information presented on 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.
This trial is open to recruitment at the following locations. Contact your preferred location at their email address.
Contact the Clinical Trials team
- Greater Manchester Dementia Research Centre: coming soon
- National Hospital for Neurology and Neurosurgery (UCLH), London: [email protected]
- Queen Elizabeth University Hospital, Glasgow: [email protected]
- Royal Hallamshire Hospital, Sheffield: coming soon
- University Hospital Southampton: coming soon
What is the aim of the study?
This study is testing a new medicine called ALN 5288 for people with Alzheimer’s disease. ALN 5288 is a treatment that helps the body make less of a protein called tau. Too much tau in the brain can cause it to clump together, which may lead to memory and thinking problems.
The medicine works by finding and breaking down the instructions inside cells that tell the body to make tau. By reducing tau production, the aim is to lower tau levels, and so slow down the changes in the brain caused by Alzheimer’s disease. The medicine is given as an injection into the space around the spine so it can reach the brain more directly.
What the study wants to find out
The study has two main goals:
- To check if ALN 5288 is safe for people with Alzheimer’s disease and to see how well people can tolerate it.
- To learn how the medicine works inside the body, including what it does and how the body uses and clears it after it is given.
How the study is carried out
This study is a double-blind placebo-controlled trial. This means:
- Some people will get ALN 5288.
- Some people will get a placebo (a dummy treatment that has no medicine in it).
Neither the participant, their study doctor, nor the study team will know who is getting which treatment during the first part of the study. This helps make the results fair.
In the second part of the study, everyone will get ALN 5288, no matter what they received at the start. This part is called an open label extension, because everyone and their doctors will know they are getting the real medicine.
Find more information about why studies use blinding, randomisation and placebo controls.
Who can participate
- People who have a diagnosis of Alzheimer's disease based on clinical findings supported by cerebrospinal fluid (CSF) biomarkers or positive positron emission tomography (PET) amyloid imaging within 7 years prior to screening.
- People who have mild cognitive impairment (MCI) or dementia due to Alzheimer’s Disease
- People who are able and willing to meet all study requirements in the opinion of the Investigator
- To take part in this study you must have a study partner (a close friend or family member who has regular contact with you and can provide information at study visits).
Who cannot participate
- People who have a known human immunodeficiency virus infection, or who have a history of hepatitis C virus or current hepatitis B virus infection.
- People who have a history of uncontrolled seizures within the last 6 months prior to screening.
- People who have a medical history of a brain or spinal disease that would interfere with spinal injections.
- People who have been hospitalised for any major medical or surgical procedure involving general anaesthetic within 12 weeks of screening, or, people who are scheduled to have a major medical or surgical procedure involving general anaesthetic at any point during the trial.
Other specific medical criteria will apply, which a study doctor will discuss with you and evaluate.
Clinical trial team
Who can participate
- People who have a diagnosis of Alzheimer's disease based on clinical findings supported by cerebrospinal fluid (CSF) biomarkers or positive positron emission tomography (PET) amyloid imaging within 7 years prior to screening.
- People who have mild cognitive impairment (MCI) or dementia due to Alzheimer’s Disease
- People who are able and willing to meet all study requirements in the opinion of the Investigator
- To take part in this study you must have a study partner (a close friend or family member who has regular contact with you and can provide information at study visits).
Who cannot participate
- People who have a known human immunodeficiency virus infection, or who have a history of hepatitis C virus or current hepatitis B virus infection.
- People who have a history of uncontrolled seizures within the last 6 months prior to screening.
- People who have a medical history of a brain or spinal disease that would interfere with spinal injections.
- People who have been hospitalised for any major medical or surgical procedure involving general anaesthetic within 12 weeks of screening, or, people who are scheduled to have a major medical or surgical procedure involving general anaesthetic at any point during the trial.
Other specific medical criteria will apply, which a study doctor will discuss with you and evaluate.