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Repurposing Siponimod for Alzheimer's Disease
NCT06639282 · View on ClinicalTrials.gov ↗
Study Summary
Collaboration with multiple sclerosis (MS) specialty colleagues led us to formulate the central hypothesis that Siponimod could lower the rate of brain atrophy in Alzheimer's disease (AD) subjects. To test our central hypothesis, we will carry out an 18-month Phase II, double-blind, randomized, twoarmed, placebo controlled, proof-of-concept clinical study in early AD subjects (i.e. mild AD) who will be receiving an escalating dose of Siponimod or placebo in the ratio 2:1 for 12 months, followed by a 6-month washout period. The primary outcome measures are safety and tolerability of Siponimod in mild AD subjects. The secondary outcome measures are the rates of brain atrophy derived from volumetric MRI (vMRI) as a proxy for neurodegeneration conducted at baseline, 6, 12, and 18 months. The tertiary outcome measures are the changes in cognition and the levels of AD-associated (e.g., Aβ and tau) and inflammatory biomarkers in CSF after Siponimod exposure. In an exploratory effort, we will also measure plasma inflammatory markers during the entire duration of the study to investigate whether one or more of these markers can be used as dynamic surrogate markers of treatment response. Using our unique experience with the repurposing of immunomodulatory drugs for AD (and NCT #04032626), in the present project we are using elements of clinical trial design that we believe were successful and made some adjustments to fit the pharmacologic and toxic properties of Siponimod.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Siponimod
Study Locations (1)
Arizona
- St. Joseph's Hospital and Medical Center — Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2025-08-26 |
| Est. Completion | 2029-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06639282
The ClinicalTrials.gov registry entry for NCT06639282 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Joseph's Hospital and Medical Center, Phoenix, which has 39 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06639282 reports 1 study location spanning 1 distinct geographic area — top geographies include Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06639282 about?
NCT06639282 is a clinical study titled "Repurposing Siponimod for Alzheimer's Disease". Collaboration with multiple sclerosis (MS) specialty colleagues led us to formulate the central hypothesis that Siponimod could lower the rate of brain atrophy in Alzheimer's disease (AD) subjects. To test our central hypothesis, we will carry out an 18-month Phase II, double-blind, randomized, twoa...
What is the current status of trial NCT06639282?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2025-08-26. Estimated completion is 2029-10.
What conditions does trial NCT06639282 study?
This clinical trial studies the following conditions: Alzheimer Disease, Cognitive Impairment, Mild, Mild Alzheimer Disease, MCI With Increased Risk for Alzheimer Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06639282?
The interventions under investigation include: Placebo (DRUG), Siponimod (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06639282?
This trial is sponsored by St. Joseph's Hospital and Medical Center, Phoenix, which has 39 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06639282 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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