NCT07214727RecruitingPhase 1
A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease
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
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 6 Oct 2025
- Start date
- 15 Oct 2025
- Primary completion date
- 6 Mar 2030
- Lead sponsor
- Alnylam Pharmaceuticals
- Diseases
- Alzheimer disease
- NCT number
- NCT07214727
- EU CT number
- 2025-522582-30-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 50
- From 15 Oct 2025 to the primary completion date, 6 Mar 2030
- 13 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has history of uncontrolled seizures within the last 6 months prior to Screening
Other illness
- Has non-AD dementia
- Has known human immunodeficiency virus infection
- Has history of hepatitis C virus or current hepatitis B virus infection
- 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
Lab values
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2× upper limit of normal (ULN)
- Has total bilirubin \>1.5×ULN
- Has an estimated glomerular filtration (eGFR) of \<45 mL/min/1.73 m\^2 at screening
Other
- Has systolic blood pressure \>160 mmHg and/or a diastolic blood pressure \>100 mmHg after 10 minutes of rest at screening
- Has clinically significant ECG abnormalities at screening
Who the study is looking for
- 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
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Trial Site Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Clinical Trial Site Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| Clinical Trial Site Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitari General de Catalunya Coordinator of this site? Confirm its status | Sant Cugat del Vallès | Spain | Recruiting |
| Clinical Trial Site Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
| Clinical Trial Site Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Clinical Trial Site Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| Clinical Trial Site Coordinator of this site? Confirm its status | Southampton | United Kingdom | Recruiting |
| Brain Research Center Amsterdam B.V. Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Brain Research Center Den Bosch B.V. Coordinator of this site? Confirm its status | 's-Hertogenbosch | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.