50 Participants Needed

ALN-5288 for Alzheimer's Disease

Recruiting at 11 trial locations
CT
Overseen ByClinical Trial Information Line
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Alnylam Pharmaceuticals

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ALN-5288 for Alzheimer's Disease. Researchers aim to determine if ALN-5288 is safe and how it behaves in the body when injected into the spine. The study involves two groups: one receives ALN-5288 immediately, while the other starts with a placebo (a harmless substance) and later receives ALN-5288. Suitable candidates for this trial have Alzheimer's Disease with mild memory issues or dementia and have already undergone tests like a brain scan or spinal fluid check to confirm the diagnosis. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

Is there any evidence suggesting that ALN-5288 is likely to be safe for humans?

Research shows that ALN-5288 is being tested for safety and tolerability in people with Alzheimer's Disease. As a Phase 1 study, this likely marks the first administration of ALN-5288 to humans. Phase 1 trials typically involve a small group to ensure safety. Consequently, there is limited information on how participants handle ALN-5288 or any potential side effects. The primary goal is to identify any major safety concerns. If well-tolerated, future studies will further examine its effectiveness and any possible side effects.12345

Why do researchers think this study treatment might be promising for Alzheimer's?

Unlike standard Alzheimer's treatments, which often focus on managing symptoms with drugs like donepezil or memantine, ALN-5288 introduces a novel approach. Researchers are excited about ALN-5288 because it may target the underlying mechanisms of Alzheimer's disease rather than just alleviating symptoms. This treatment has a unique mechanism of action that could potentially modify the disease's progression, offering hope for more effective long-term management of Alzheimer's.

What evidence suggests that ALN-5288 might be an effective treatment for Alzheimer's Disease?

Research shows that ALN-5288 is under investigation as a potential treatment for Alzheimer's disease. The trial includes two treatment arms: one where participants receive ALN-5288 throughout the study, and another where participants receive a placebo during the Double-blind Period and ALN-5288 during the Open-Label Extension Period. The treatment is administered by injection into the spinal canal. The study aims to understand the drug's effects on the brain and body by examining its mechanism and pharmacokinetics. Detailed results on efficacy are not yet available, as the study primarily focuses on assessing safety and understanding the drug's function in the body. Early findings emphasize safety rather than proven effectiveness for treating Alzheimer's.12356

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Alnylam Pharmaceuticals Inc

Are You a Good Fit for This Trial?

This trial is for patients with Alzheimer's Disease who can safely receive injections into their spinal canal (intrathecal). Specific eligibility details are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

Is able and willing to meet all study requirements in the opinion of the Investigator
I have been diagnosed with Alzheimer's based on tests or a PET scan within the last 7 years.
I have been diagnosed with mild cognitive impairment or Alzheimer's disease.

Exclusion Criteria

Has non-AD dementia
Has alanine aminotransferase (ALT) or aspartate aminotransferase >2× upper limit of normal (ULN)
Has total bilirubin >1.5×ULN
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-blind Treatment

Participants receive either placebo or ALN-5288 to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics

Open-label Extension

Participants receive ALN-5288 to continue evaluating safety and tolerability

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ALN-5288
Trial Overview The study is testing ALN-5288, a new treatment given by spinal injection to see if it's safe and how it affects people with Alzheimer's. It will be compared to a placebo (a harmless substance), and researchers will monitor how the body processes the drug.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ALN-5288Experimental Treatment1 Intervention
Group II: Placebo + ALN-5288Placebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alnylam Pharmaceuticals

Lead Sponsor

Trials
81
Recruited
16,100+

Dr. Yvonne Greenstreet

Alnylam Pharmaceuticals

Chief Executive Officer since 2021

MD from the University of Leeds, MBA from INSEAD

Dr. Pushkal Garg

Alnylam Pharmaceuticals

Chief Medical Officer since 2016

MD from Columbia University

Regeneron Pharmaceuticals

Industry Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Citations

A Study to Evaluate ALN-5288 in Patients With Alzheimer's ...These data include demographics, such as age, sex/gender, race and ethnicity, and study-specific measures (for example, systolic blood pressure, ...
2.clinicaltrials.alnylam.comclinicaltrials.alnylam.com/trials/7214727
ALN-5288-001 - Alnylam Clinical TrialsThe purpose of this study is to: - Evaluate the safety and tolerability of intrathecal (IT) ALN-5288 in patients with Alzheimer's Disease (AD) - Evaluate ...
A Study to Evaluate ALN-5288 in Patients With Alzheimer's ...The purpose of this study is to: * Evaluate the safety and tolerability of intrathecal (IT) ALN-5288 in patients with Alzheimer's Disease ...
ALN-5288 for Alzheimer's Disease · Info for ParticipantsThis trial is for patients with Alzheimer's Disease who can safely receive injections into their spinal canal (intrathecal). Specific eligibility details are ...
Alnylam and Regeneron Join Forces in Promising ...The study aims to assess the safety, tolerability, and pharmacokinetic and pharmacodynamic effects of ALN-5288 in patients with Alzheimer's ...
A Study to Evaluate ALN-5288 in Patients With Alzheimer's ...The purpose of this study is to: Evaluate the safety and tolerability of intrathecal (IT) ALN-5288 in patients with Alzheimer's Disease (AD) ...
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