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Looking for participantsPhase1

A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease

Sponsor: Alnylam Pharmaceuticals

NCT ID: NCT07214727

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
ALN-5288 (drug), Placebo (drug)
How long the study runs
Study runs about 53 months (dates as stated)
About the drug or intervention
ALN-5288 — drug: ALN-5288 will be administered IT. · Placebo — drug: Placebo will be administered IT.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
40 Years to 80 Years
Who
All
Number of participants
50
Started
2025-10-15
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for alzheimer's disease
  • • Phase1 - 50 participants
  • • 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

Who can take part?

  • • Ages 40 Years to 80 Years
  • • Diagnosed with alzheimer's disease

Where?

  • • Glasgow - Clinical Trial Site
  • • London - Clinical Trial Site
  • • Sheffield - Clinical Trial Site
  • • Southampton - Clinical Trial Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Alzheimer's Disease

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 40 Years - 80 Years
  • Who can join: All genders

Biomarkers mentioned

biomarkers or positiveeGFR

What the study is looking for

  • ✓Is able and willing to meet all study requirements in the opinion of the Investigator
  • ✓Has mild cognitive impairment (MCI) or dementia due to AD

Who cannot take part

  • ✗Has non-AD dementia
  • ✗Has alanine aminotransferase (liver enzymes) or aspartate aminotransferase (liver enzymes) \>2× upper limit of normal (ULN)
  • ✗Has total liver blood test \>1.5×ULN
  • ✗Has known human immunodeficiency virus infection
  • ✗Has history of hepatitis C virus or current hepatitis B virus infection
See the full 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

Where Is This Study? (4 UK sites)

Clinical Trial Site

Glasgow G51 4TF, United Kingdom

Recruiting

Clinical Trial Site

London WC1N 3BG, United Kingdom

Recruiting

Clinical Trial Site

Sheffield S10 2JF, United Kingdom

Recruiting

Clinical Trial Site

Southampton SO16 6YD, United Kingdom

Recruiting

How to Get in Touch

Clinical Trial Information Line

Sponsor contact

CONTACT

1-877-ALNYLAM clinicaltrials@alnylam.com

Clinical Trial Information Line

Sponsor contact

CONTACT

1-877-256-9526 clinicaltrials@alnylam.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10