ALN-5288 for Alzheimer's Disease
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
What Are the Treatments Tested in This Trial?
Interventions
- ALN-5288
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alnylam Pharmaceuticals
Lead Sponsor
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
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School