Repurposing Siponimod for Alzheimer's Disease

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Study ID
NCT06639282
Phase
PHASE2
Status
Recruiting
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Conditions

  • Alzheimer Disease
  • Cognitive Impairment, Mild
  • MCI With Increased Risk for Alzheimer Disease
  • Mild Alzheimer Disease

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Siponimod — DRUG
    Siponimod (formerly known as BAF312 and completed trial NCT #01665144) has been FDA approved since 2019 (IND #076122) for the treatment of multiple sclerosis. Siponimod is an immunomodulator that prevents the egression of T lymphocytes from peripheral lymphoid organs.
  • Placebo — DRUG
    A placebo that resembles siponimod will be given once daily to participants randomly assigned into the placebo arm.

Study Details

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.

Key Dates

Start date
Aug 26, 2025
Status verified
May 2025
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Drug Arm
    Randomly assigned subjects who will receive an escalating dose of Siponimod (0.25-1 mg/day) for 12 months.
  • Placebo Comparator: Placebo Arm
    Randomly assigned subjects who will receive a placebo daily for 12 months.

Primary Outcome Measure

Monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Joseph's Hospital and Medical CenterPhoenixArizona85013
Connie Hillis
[email protected]
602-406-5128
Marwan Sabbagh, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
St. Joseph's Hospital and Medical Center· Phoenix, AZ

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