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NCT06639282 · ClinicalTrials.gov registry record · Phase 2
Repurposing Siponimod for Alzheimer's Disease
A Phase 2 study of Alzheimer Disease and Cognitive Impairment, Mild, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
- 1
- Study location
NCT06639282: Recruiting Phase 2 study of Alzheimer Disease and Cognitive Impairment, Mild, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
NCT06639282 is a Phase 2 study of Alzheimer Disease and Cognitive Impairment, Mild that is actively recruiting participants, run by St. Joseph's Hospital and Medical Center, Phoenix. The registered enrollment target is 105 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06639282, a Phase 2 study of Alzheimer Disease and Cognitive Impairment, Mild, is actively recruiting participants, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
To evaluate the safety and tolerability of Siponimod titrated for up to 12 months and washed out for 6 months in mild AD subjects. (Subjects will receive gradual titration regimen of Siponimod starting at 0.25mg/day and increasing every two weeks by 0.25 mg, up to final dosage of 1 mg/day.) Safety will be assessed at each study visit through completion of comprehensive tests and procedures aimed at monitoring for potentials adverse events (AEs). Study staff will also gather direct reports from s
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 |
What NCT06639282 shows while recruiting
NCT06639282 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (96% lower).
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.
NCT06639282 reports a single indexed study location in Arizona.
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.
What interventions are being tested in trial NCT06639282?
The interventions under investigation include: Placebo (DRUG), Siponimod (DRUG).
Who is sponsoring clinical trial NCT06639282?
This trial is sponsored by St. Joseph's Hospital and Medical Center, Phoenix, which has 44 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Alzheimer Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06639282's enrollment target sits among peer trials
105 148th of 306 higher than 159 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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