Is NCT06996652 recruiting in Aurora, CO?

Yes, NCT06996652 is currently enrolling participants at its Aurora, CO location. This rem sleep behavior disorder clinical trial is accepting qualified participants.

How do I join the rem sleep behavior disorder clinical trial in Aurora?

To join this clinical trial in Aurora, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Aurora clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

REM Sleep Behavior Disorder Clinical Trial in Aurora, CO: Adalimumab

About This REM Sleep Behavior Disorder Study in Aurora

This is a phase 2 study to assess the ability of adalimumab as compared to placebo to reduce or prevent progression of synuclein-related neurodegeneration in persons with idiopathic REM Sleep Behavior Disorder (RBD). The Primary Endpoint will be change from baseline in expression of the Parkinson Disease Related Pattern (PDRP) will be assessed using change in 18-flurodeoxyglucose (FDG) Positron Emission Tomography (PET) imaging.

Sponsor: Yale University

Who Can Participate

Inclusion Criteria

Males, or females who are either

post-menopausal or otherwise not of child-bearing potential, defined as either 1) having had no menses for 12 or months without an alternative medical cause or explanation or 2) having undergone a surgical procedure (hysterectomy, bilateral tubal ligation) that prevents conception, or

practicing adequate contraception. Female participants of childbearing potential must practice at least 1 protocol-specified method of birth control, that is effective from 30 days before baseline (or earlier) through at least 150 days after the last dose of the study drug. Female participants of non-childbearing potential do not need to use birth control.

Diagnosis of idiopathic REM sleep behavior disorder Diagnosis of idiopathic REM Sleep Behavior Disorder (RBD) based upon:

History of Dream Enactment Behavior during sleep and

Evidence of REM sleep without muscle atonia based upon polysomnogram obtained in a qualified sleep laboratory, consistent with ICSD-3 Diagnostic Criteria for RBD

Hyposmia, defined as score \< 15th percentile for age-and gender-specific normal values

Not diagnosed with motor parkinsonism or Lewy body dementia

Have a MoCA score at screening and baseline \>23

Able to speak, read and write fluently in the official language of the site's geographical region

Participant must be willing and able to attend all study visits as required by the study protocol

Participant must have a study partner who is in regular contact with the subject and can accompany the subject to clinic visits and report on subject's functional status

Participant must be able to self-inject study drug regularly or have a study partner who is available, willing and able to do so

Participant must be able to understand the study requirements and provide written informed consent

Exclusion Criteria

Alternative explanation or etiology for the presence of RBD (e.g. narcolepsy)

Other than RBD, neurologic or medical disorder which may impair cognition including: head trauma, seizure disorder, neurodegenerative disease, hydrocephalus, cerebral/spinal hematoma, inflammatory disease, CNS infection (e.g., encephalitis or meningitis), neoplasm, toxic exposure, metabolic disorder (including hypoxic or hypoglycemic episodes), or endocrine disorder, or any significant medical conditions that, in the opinion of the investigator, would prohibit their participation in the study.

As assessed by the central reader, MRI evidence of (a) more than three lacunar infarcts, (b) territorial infarct or macroscopic hemorrhage, or (c) deep white matter lesions corresponding to a Fazekas score of 3

Any contra-indication to undergo MRI, as judged by local PI or radiologist, including but not limited to presence of pacemaker, aneurysm clips, artificial heart valves, ear implants, ventriculoperitoneal shunt, foreign metal objects in the eyes, skin or body or any other circumstance which would contra-indicate an MRI scan or impair MRI image quality, or history of claustrophobia or of not tolerating MRI scanning procedures

History or active presence of any of the following neurological, psychiatric or medical conditions:

Large vessel stroke

Peripheral or CNS demyelinating disease

Chronic and/or recurrent fungal, bacterial or opportunistic infections

Myocardial infarction or unstable angina within the previous 12 months

Clinically relevant or significant ECG abnormalities, including ECG with QT interval corrected for heart rate using Fridericia's formula (QT interval corrected for heart rate using Fridericia's formula) \> 450 msec (males) or \> 470 msec (females).

Congestive heart failure, NYHA Class 3 or 4

Autoimmune disease (e.g., Systemic Lupus Erythematosis (SLE), or symptoms suggestive of a lupus-like syndrome, multiple sclerosis, rheumatoid arthritis, Type 1 diabetes mellitus, inflammatory bowel disease, psoriasis, etc.)

Immunocompromised systemically due to continuing effects of immune suppressing medication

Current or previous hepatitis B infection (defined as positive test for hepatitis B surface antigen (HbSAg) and/or hepatitis B core antibody (anti-HBc). Participants with immunity to hepatitis B (if due to natural infection defined as negative HBsAg, positive hepatitis B antibody (anti-HBs) and positive anti-HBc; if due to vaccination defined as negative HBsAg, negative anti-HBc and positive anti-HBs are eligible to participate in the study For patients with resolved HBV infection, if anti-HBc negative, HBV DNA testing is needed prior to initiating study drug

History or positive test at Screening for hepatitis C virus antibody (anti-HCV) in the absence of treatment resulting in cure

History or positive test at Screening for human immunodeficiency virus (HIV)

History of untreated or incompletely treated tuberculosis or a positive tuberculosis IGRA test.

History of malignancy other than successfully treated, non-metastatic cutaneous squamous or basal cell carcinoma or localized carcinoma in situ of the cervix

Major depressive episode requiring initiation of medication or hospitalization within the previous 90 days

Seated blood pressure \> 150/90 on 3 separate determinations

Presence of hallucinations or delusions

Psychiatric disorder (schizophrenia, schizoaffective disorder, etc.) associated with psychosis

Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to baseline

Major surgery within 12 weeks of screening

Blood donation of 1 unit or more within 8 weeks prior to the first dose of study medication

Any of the following laboratory abnormalities at Screening

Screening values for hemoglobin \< 12 g/d for men or \< 11 g/dL for women or other clinically significant hematological abnormality

Any serum chemistry value (e.g., AST, ALT, alkaline phosphatase, CK, total bilirubin etc. \> 2x the upper limit of normal on 2 successive determinations less than 2 weeks apart

Serum creatinine above the ULN or eGFR \< 60 mL/min/1.73 m2

Platelet count, INR, PT or PTT not within the normal range or other risk for increased or uncontrolled bleeding

Any other significant medical conditions that, in the opinion of the investigator, would prohibit participation in the study, including inability to tolerate the MRI scan

For participants agreeing to lumbar puncture: Presence of contra-indication to lumbar puncture as judged by local PI (e.g., known X-ray or other evidence of significant lumbar spine abnormalities or history of lumbar surgery with sequalae that would interfere with or pose risks from the procedure; platelet count below 50,000 cells/mL; need for anticoagulant or antiplatelet medications other than aspirin at a dose of \< 100 mg/day or clopidogrel (see item 10 (g) below))

Taking any of the following medications:

Symptomatic anti-Parkinson agents, including but not limited to levodopa-containing preparations, dopamine agonists, monoamine oxidase inhibitors, amantadine, and adenosine receptor antagonists taken any time prior to the screening visit

Cognitive enhancing agents, including but not limited to acetylcholinesterase inhibitors and memantine taken any time prior to the screening visit

Stimulant medications, including but not limited to lisdexamphetamine, dextroamphetamine/amphetamine (Adderall) and methylphenidate taken at any time prior to the screening visit

Antipsychotic agents, including pimavanserin

Antidepressant medications whose dose has not been stable for at least 90 days

Use of any of the following medications within 12 months prior to Screening: Immunosuppressant medications, including chronic corticosteroids, anakinra and abatacept

Any previous use of injected or infused antibody therapies, including but not limited antibodies directed against TNF, anti-IL-6, natalizumab, rituximab, conventional or targeted DMARD agents

For participants agreeing to undergo lumbar puncture: Anticoagulant or anti-platelet medications including warfarin, heparinoids and direct coagulation factor inhibitors (e.g., apixaban, dabigatran, rivaroxaban) within 90 days of the planned first dose of study drug; either aspirin at a dose of \<¬ 100 mg/day or clopidogrel at a dose of 75 mg/day, but use of both in combination is permitted.

Received any live vaccine, with the exception of non-replicating live viral vaccines such as Jynneos vaccine, within 30 days prior to the first dose of study drug, or expected need of live vaccination during study participation including at least 70 days after the last dose of study drug.

History of an allergic reaction or significant sensitivity to adalimumab or constituents of the study drug (and its excipients) and/or other products in the same class

Participation in any other interventional clinical trial, or treatment with any investigational drug or investigational use of an approved therapy within 30 days (or 5 half-lives of such agent) prior to the first Screening visit.

History of drug or alcohol abuse within the last 5 years (including cannabis use disorder)

Positive urine drug test at screening

Unwillingness or inability to comply with study requirements, including self-administration of study medication, or history of noncompliance in prior clinical trials

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Aurora?

Yes, this clinical trial (NCT06996652) has an active research site in Aurora, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

REM Sleep Behavior Disorder Treatment Options in Aurora, CO

If you're searching for rem sleep behavior disorder treatment options in Aurora, CO, this clinical trial (NCT06996652) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Aurora research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced rem sleep behavior disorder specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all rem sleep behavior disorder clinical trials near you to find additional studies recruiting in your area.

REM Sleep Behavior Disorder Clinical Trial in Aurora, CO

Expert Care in Aurora

IRB Approved

No-Cost Care

Apply for This Aurora Location

Why Participate?

Simple Process