Alzheimer's Disease study: ALN-5288
Official title A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease
ClinicalTrials.gov ID: NCT07214727
What this study is testing
What is ALN-5288?
This is an investigational medicine being studied as a potential treatment for Alzheimer's Disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether ALN-5288 is safe and how it behaves in the body when given into the spinal fluid.
- Who it's for
- You may be able to join if you have Alzheimer’s disease and meet the study’s health criteria.
- What's involved
- You will receive a small amount of ALN-5288 injected into your spinal fluid. You will have check‑ups and blood tests to see how the drug works and if it causes any problems.
- Time commitment
- The study lasts a few weeks, with several visits for injections and monitoring.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- Is able and willing to meet all study requirements in the opinion of the Investigator
- Has a diagnosis of Alzheimer's disease (AD) based on clinical findings supported by cerebrospinal fluid (CSF) biomarkers or positive positron...
- Has mild cognitive impairment (MCI) or dementia due to AD
You likely can't join if
- Has non-AD dementia
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2× upper limit of normal (ULN)
- Has total bilirubin \>1.5×ULN
- Has known human immunodeficiency virus infection
- Has history of hepatitis C virus or current hepatitis B virus infection
- Has systolic blood pressure \>160 mmHg and/or a diastolic blood pressure \>100 mmHg after 10 minutes of rest at screening
See the full eligibility criteria
- Is able and willing to meet all study requirements in the opinion of the Investigator
- Has a diagnosis of Alzheimer's disease (AD) based on clinical findings supported by cerebrospinal fluid (CSF) biomarkers or positive positron emission tomography (PET) amyloid imaging within 7 years prior to screening
- Has mild cognitive impairment (MCI) or dementia due to AD
- Has non-AD dementia
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2× upper limit of normal (ULN)
- Has total bilirubin \>1.5×ULN
- Has known human immunodeficiency virus infection
- Has history of hepatitis C virus or current hepatitis B virus infection
- Has systolic blood pressure \>160 mmHg and/or a diastolic blood pressure \>100 mmHg after 10 minutes of rest at screening
- Has an estimated glomerular filtration (eGFR) of \<45 mL/min/1.73 m\^2 at screening
- Has clinically significant ECG abnormalities at screening
- Has uncontrolled psychiatric disease, including patients deemed by the Investigator to be at significant risk of suicide, major depressive episode, psychosis, confusional state, or violent behavior
- Has history of bleeding diathesis or coagulopathy due to chronic conditions
- Has a medical history of brain or spinal disease that would interfere with the IT injection and LP procedures
- Has history of uncontrolled seizures within the last 6 months prior to Screening
The study team makes the final eligibility decision.
Where it is enrolling
- Montreal, Canada
- Ottawa, Canada
- Toronto, Canada
- 's-Hertogenbosch, Netherlands
- Amsterdam, Netherlands
- Madrid, Spain
- Glasgow, United Kingdom
- London, United Kingdom
- Sheffield, United Kingdom
- Southampton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Montreal, Canada; Ottawa, Canada; Toronto, Canada; 's-Hertogenbosch, Netherlands; Amsterdam, Netherlands; Madrid, Spain and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.