Alzheimer's Disease / ALN-5288 · Phase 1 Trial

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

ClinicalTrials.gov · August 14, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 1 trial registration for ALN-5288, an investigational intrathecal agent in Alzheimer's disease, currently recruiting with no results yet posted. The study is designed to evaluate safety, tolerability, and pharmacodynamic/pharmacokinetic effects in a small cohort over up to 32 months; any clinical conclusions cannot be drawn from the registry record alone.

What was studied

Phase 1, Interventional, Randomized, Parallel, Triple masking, Treatment purpose. Alzheimer's Disease; age from 40 Years; to 80 Years. Intervention: ALN-5288. Compared with: Placebo + ALN-5288 — Placebo Comparator. n = 50. 13 sites across 4 countries.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This early-phase trial cannot yet inform clinical practice. Clinicians should monitor for publications of safety and pharmacodynamic results once the trial is complete and analysed.

Plain-language summary

This is a Phase 1 trial registration with no posted results; it is an early-stage safety and tolerability study in a small estimated cohort designed to establish feasibility and dose range.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Frequency of Adverse Events (AEs) (assessed at Up to 32 months); Severity of AEs (assessed at Up to 32 months)

DesignPhase 1, Interventional, Randomized, Parallel, Triple masking, Treatment purpose

PopulationAlzheimer's Disease; age from 40 Years; to 80 Years

Sample size50

InterventionALN-5288

ComparatorPlacebo + ALN-5288 — Placebo Comparator

Setting13 sites across 4 countries

Reported figures

Quoted from the source exactly as published.

Estimated enrollment50

Study phasePHASE1

Primary outcome measure 1Frequency of Adverse Events, Up to 32 months

Primary outcome measure 2Severity of AEs, Up to 32 months

Clinical bottom line

This early-phase trial cannot yet inform clinical practice. Clinicians should monitor for publications of safety and pharmacodynamic results once the trial is complete and analysed.

Caveats

No results are posted in this registry record; all outcomes remain unreported.
Phase 1 design limits generalizability to treatment efficacy; efficacy outcomes are not primary endpoints.
Follow-up duration up to 32 months stated for outcome measurement, but enrolment and baseline characteristics not specified.
Placebo comparator noted but randomization scheme, blinding method, and dose escalation strategy not described in registry record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 1 interventional trial with placebo comparator; early-stage design.

Directness

moderate

Primary outcomes are safety and tolerability; pharmacodynamic and pharmacokinetic measures are surrogate endpoints.

Consistency

insufficient

No results posted; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Registry record provides no methodological detail on randomization, blinding, or outcome assessment.

Sample adequacy

limited

Estimated enrollment 50 participants; typical Phase 1 size, insufficient for efficacy claims.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07214727). This is a study registration, not published results. Lead sponsor: Alnylam Pharmaceuticals. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 50 participants (ESTIMATED). Conditions: Alzheimer's Disease. Interventions: DRUG: ALN-5288; DRUG: Placebo. Primary outcome measures: Frequency of Adverse Events (AEs) , Up to 32 months; Severity of AEs , Up to 32 months. Brief summary: 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

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Alzheimer's DiseaseNCT07214727Alnylam PharmaceuticalsALN-5288