Actively Recruiting
A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease
Led by Alnylam Pharmaceuticals · Updated on 2026-05-14
50
Participants Needed
13
Research Sites
229 weeks
Total Duration
On this page
Sponsors
A
Alnylam Pharmaceuticals
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to meet all study requirements as judged by the Investigator
- Diagnosis of Alzheimer's disease supported by cerebrospinal fluid biomarkers or positive PET amyloid imaging within 7 years prior to screening
- Has mild cognitive impairment or dementia due to Alzheimer's disease
You will not qualify if you...
- Has non-Alzheimer's disease dementia
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2 times the upper limit of normal
- Has total bilirubin greater than 1.5 times the upper limit of normal
- Has known human immunodeficiency virus infection
- Has history of hepatitis C virus or current hepatitis B virus infection
- Has systolic blood pressure over 160 mmHg or diastolic blood pressure over 100 mmHg after 10 minutes rest at screening
- Has estimated glomerular filtration rate below 45 mL/min/1.73 m2 at screening
- Has clinically significant ECG abnormalities at screening
- Has uncontrolled psychiatric disease or significant risk of suicide, major depression, psychosis, confusion, or violent behavior
- Has history of bleeding disorders due to chronic conditions
- Has brain or spinal disease interfering with intrathecal injection and lumbar puncture procedures
- Has history of uncontrolled seizures within the last 6 months prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Clinical Trial Site
Montreal, Canada, H3G 1H9
Actively Recruiting
2
Clinical Trial Site
Ottawa, Canada, K1Z 1G3
Actively Recruiting
3
Clinical Trial Site
Toronto, Canada, M3B 2S7
Actively Recruiting
4
Clinical Trial Site
Toronto, Canada, M5T 2S8
Not Yet Recruiting
5
Clinical Trial Site
's-Hertogenbosch, Netherlands, 5223
Not Yet Recruiting
6
Clinical Trial Site
Amsterdam, Netherlands, 1081 GN
Not Yet Recruiting
7
Clinical Trial Site
Barcelona, Spain, 08036
Not Yet Recruiting
8
Clinical Trial Site
Madrid, Spain, 28040
Not Yet Recruiting
9
Clinical Trial Site
Sant Cugat del Vallès, Spain, 08190
Not Yet Recruiting
10
Clinical Trial Site
Glasgow, United Kingdom, G51 4TF
Not Yet Recruiting
11
Clinical Trial Site
London, United Kingdom, WC1N 3BG
Actively Recruiting
12
Clinical Trial Site
Sheffield, United Kingdom, S10 2JF
Not Yet Recruiting
13
Clinical Trial Site
Southampton, United Kingdom, SO16 6YD
Not Yet Recruiting
Research Team
C
Clinical Trial Information Line
CONTACT
C
Clinical Trial Information Line
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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