A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ALN-5288, Placebo.
- Who it may be relevant to
- Registry conditions: Alzheimer's Disease. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada, Netherlands, Spain, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Randomized, Placebo-controlled Study With a Double Blind Period With Open-label Extension Period to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ALN-5288 in Adult Patients With Alzheimer's Disease
Overview
The purpose of this study is to: * Evaluate the safety and tolerability of intrathecal (IT) ALN-5288 in patients with Alzheimer's Disease (AD) * Evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) effects of ALN-5288 after dose administration
Interventions
- Drug ALN-5288
ALN-5288 will be administered IT. - Drug Placebo
Placebo will be administered IT.
Primary outcome measures
- Frequency of Adverse Events (AEs) [Time frame: Up to 32 months]
- Severity of AEs [Time frame: Up to 32 months]
Secondary outcome measures (7)
- Concentration of Total Tau (t-Tau) Protein in CSF Over Time [Time frame: Up to 32 months]
- Change from Baseline in Concentration of t-Tau Protein in CSF Over Time [Time frame: Up to 32 months]
- Concentration of ALN-5288 in Plasma Over Time (Ct) [Time frame: Up to 32 months]
- Change from Baseline in Concentration of ALN-5288 CSF Ct [Time frame: Up to 32 months]
- Concentration of ALN-5288 in Plasma [Time frame: Up to 32 months]
- Concentration of ALN-5288 in Urine [Time frame: Up to 32 months]
- Concentration of ALN-5288 in CSF [Time frame: Up to 32 months]
Eligibility criteria
Inclusion 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Canada · 4 centers
- Clinical Trial Site — Montreal
- Clinical Trial Site — Ottawa
- Clinical Trial Site — Toronto
- Clinical Trial Site — Toronto
United Kingdom · 4 centers
- Clinical Trial Site — Glasgow
- Clinical Trial Site — London
- Clinical Trial Site — Sheffield
- Clinical Trial Site — Southampton
Spain · 3 centers
- Clinical Trial Site — Barcelona
- Clinical Trial Site — Madrid
- Clinical Trial Site — Sant Cugat del Vallès
Netherlands · 2 centers
- Clinical Trial Site — 's-Hertogenbosch
- Clinical Trial Site — Amsterdam
Identifiers
NCT: NCT07214727 · ALN-5288-001 · 2025-522582-30-00