Actively Recruiting
A Phase 1, Randomized, Placebo-Controlled Study With Double-Blind and Open-Label Extension Periods to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecal ALN-5288 in Adults With Alzheimer's Disease
Led by Alnylam Pharmaceuticals · Updated on 2026-05-14
50
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Alnylam Pharmaceuticals
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of a drug called ALN-5288, given through a spinal injection, in adults aged 40 to 80 with Alzheimer's Disease (AD). This Phase 1 randomized study also examines how the body processes ALN-5288 and its effects after dosing. Participants have mild cognitive impairment or dementia due to AD, confirmed by specific brain scans or cerebrospinal fluid tests within seven years before screening. Participants are randomly assigned to receive either ALN-5288 or a placebo during the double-blind period. After this, all participants receive ALN-5288 in an open-label extension phase. Both ALN-5288 and placebo are administered intrathecally (into the spinal fluid). The study tracks participants for up to 32 months from the first dose to monitor treatment effects and safety. During the study, participants undergo regular assessments including monitoring of any adverse events, blood and urine tests to measure ALN-5288 levels, and cerebrospinal fluid tests to evaluate biomarkers related to Alzheimer's Disease. Researchers carefully observe the frequency and severity of any side effects. The study aims to gather detailed information on how the drug behaves in the body and its impact, while ensuring participant safety over the long follow-up period.
CONDITIONS
Brief 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
- Diagnosed with Alzheimer's disease based on clinical findings supported by cerebrospinal fluid biomarkers or positive PET amyloid imaging within 7 years before screening
- Has mild cognitive impairment or dementia due to Alzheimer's disease
- Age between 40 and 80 years
You will not qualify if you...
- Diagnosed with non-Alzheimer's dementia
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 2 times the upper limit of normal
- Total bilirubin greater than 1.5 times the upper limit of normal
- Known HIV infection
- History of hepatitis C or current hepatitis B infection
- Systolic blood pressure over 160 mmHg or diastolic blood pressure over 100 mmHg after 10 minutes rest at screening
- Estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m² at screening
- Clinically significant ECG abnormalities at screening
- Uncontrolled psychiatric conditions including high suicide risk, major depression, psychosis, confusion, or violent behavior
- History of bleeding disorders due to chronic conditions
- Medical history of brain or spinal diseases interfering with spinal injection and lumbar puncture
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 32 months
Participants receive intrathecal administration of ALN-5288 or placebo during the double-blind period, followed by open-label extension where all participants receive ALN-5288.
Regular visits during both double-blind and open-label extension periods
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
C
Clinical Trial Information Line
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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