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New treatment option for Alzheimer Disease
Official title Repurposing Siponimod for Alzheimer's Disease
ClinicalTrials.gov ID: NCT06639282
What this study is testing
What is Siponimod?
Siponimod is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for alzheimer disease.
Also referred to as Mayzent.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join if
- Male or female at least 50 years of age, but less than 85 (84 at time of screening)
- Females must be of non-childbearing potential or have negative pregnancy test at time of screening. Women of non-childbearing potential are defined...
- Must have a diagnosis of mild Alzheimer's Dementia determined by medical record review.
- Vision and hearing must be sufficient to comply with study procedures.
- Be able to take oral medications.
You likely can't join if
- Taking one of the following medications: Medications for treatment of cancer or other drugs that weaken the immune system (ex. Natalizumab and...
- Current active infection in participants including, but not limited to, herpes zoster, herpes infection, bronchitis, sinusitis, upper respiratory...
- If participant received mRNA COVID-19 vaccination, must have received last dose at least 3 months prior to first dose of study drug/placebo.
- Current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia, including (but not...
- Meets DSM IV criteria for any major psychiatric disorder including psychosis, major depression and bipolar disorder.
- Known history of or self-reported active alcohol and/ or substance abuse within the past three years.
See the full eligibility criteria
Who can join
- Male or female at least 50 years of age, but less than 85 (84 at time of screening)
- Females must be of non-childbearing potential or have negative pregnancy test at time of screening. Women of non-childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral...
- Must have a diagnosis of mild Alzheimer's Dementia determined by medical record review.
- Vision and hearing must be sufficient to comply with study procedures.
- Be able to take oral medications.
- Must be able to attend all study visits indicated in the schedule of visits.
- Must have a collateral informant/study partner who has significant direct contact with the patient at least 10 hours per week and who is willing to accompany the patient to specified clinic visits, supervise...
- Documented Mini Mental State Exam (MMSE) score between 20-26 at Screening Visit Day 1.
- CT or MRI scan of the brain within 12 months of Screening Visit Day 1 showing no evidence of significant focal lesions or other pathology which could contribute to dementia. If neither a CT or a MRI scan is available...
- Hachinski ischemic score must be \< 4.
- Geriatric depression scale must be \< 10.
- Prior to dosing all assigned by chance study people must show proof they have received immunization to varicella (VZV IgG).
- Each patient must be assessed for capacity to consent by the principal or sub-investigators in order to provide informed consent. If the patient is deemed unable to provide informed consent, they must have a legally...
- No active suicidality identified on Columbia-Suicide Severity Rating Scale (C-SSRS).
- Patients with stable prostate cancer may be included at the discretion of the Medical Monitor.
- Patients who are on monoclonal antibody medication for the treatment of Alzheimer's (ex. lecanemab, donanemab) for \> 6 months or have discontinued monoclonal antibody medication for the treatment of Alzheimer's for \>...
What rules you out
- Taking one of the following medications: Medications for treatment of cancer or other drugs that weaken the immune system (ex. Natalizumab and Rituximab), Amiodarone, Bishydroxycoumarin, Chloramphenicol, Cimetidine...
- Current active infection in participants including, but not limited to, herpes zoster, herpes infection, bronchitis, sinusitis, upper respiratory infection and fungal skin infection. Siponimod may increase the risk in...
- If participant received mRNA COVID-19 vaccination, must have received last dose at least 3 months prior to first dose of study drug/placebo.
- Current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia, including (but not limited to) epilepsy, focal brain lesion, Parkinson's disease, seizure...
- Meets DSM IV criteria for any major psychiatric disorder including psychosis, major depression and bipolar disorder.
- Known history of or self-reported active alcohol and/ or substance abuse within the past three years.
- Isolated living circumstances which would prohibit a study partner from providing sufficient and credible information about the participant.
- Poorly controlled hypertension
- Known Atrioventricular heart block, known heart block type I-III.
- History of myocardial infarction or signs or symptoms of unstable coronary artery disease within the last year (including revascularization procedure/angioplasty).
- Severe pulmonary disease (including chronic obstructive pulmonary disease) requiring more than 2 hospitalizations within the past year.
- Untreated obstructive sleep apnea.
- Any thyroid disease (unless euthyroid on treatment for at least 6 months prior to screening).
- Active neoplastic disease (except for skin tumors other than melanoma) within five years.
- Absolute lymphocytopenia of \<1,000/mm3, or a history of lymphocytopenia within the past two years.
- Absolute neutropenia of \<1,000/mm3, or a history of neutropenia within the past two years.
- History of/ or current thromboembolism (including deep venous thrombosis).
- Any clinically significant hepatic or renal disease (including presence of Hepatitis B or C surface antigen or an elevated transaminase levels of greater than 2x the upper limit of normal (ULN) or creatinine greater...
- Clinically significant hematologic or coagulation disorder including any unexplained anemia, or a platelet count less than 100,000/µL at screening.
- Use of any investigational drug within 30 days or within five half-lives of the investigational agent, whichever is longer.
- Unwilling or unable to undergo CT or MRI imaging.
- In the opinion of the investigator, participation would not be in the best interest of the subject.
- people with CYP2C9\ 3/\ 3 genotyping
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.