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A message from Dr. David C. Weisman, Director of Clinical Research

Clinical Trials

Click on a trial to learn more:

Alzheimer’s disease

Eisai BAN2401 Enrolling Closed to enrollment Pending
Etheral Enrolling Closed to enrollment Pending
S-Citad Enrolling Closed to enrollment Pending
T2 Protect Enrolling Closed to enrollment Pending
TRAILBLAZER-ALZ Enrolling Closed to enrollment Pending
TRAILBLAZER-ALZ 2 Enrolling Closed to enrollment Pending

Lewy body dementia

Presence Enrolling Closed to enrollment Pending

Migraine

Allergan Enrolling Closed to enrollment Pending

Multiple sclerosis

Affinity Enrolling Closed to enrollment Pending
Biogen 231MS201 Enrolling Closed to enrollment Pending
Exchange Enrolling Closed to enrollment Pending
MS200527_0080 Enrolling Closed to enrollment Pending
Opera/Veloce Enrolling Closed to enrollment Pending

Parkinson’s disease

Boundless Enrolling Closed to enrollment Pending
Glide Enrolling Closed to enrollment Pending

At Abington Neurological Associates, we are committed to offering cutting-edge treatments for our patients. Clinical trials are available in many different areas. If you are interested in learning more about any of the trials that we offer, call us at 215-957-9250, or submit your contact information and our office will reach out to you.

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Eisai BAN2401 — Alzheimer’s disease

A Study to Evaluate Safety, Tolerability, and Efficacy of BAN2401 in Subjects With Early Alzheimer’s Disease
BAN2401 has been shown to be capable of clearing diffuse amyloid plaques, suggesting that it has the potential to neutralize species that provoke synaptotoxic events and to alter plaque formation in the brain. This study hypothesizes that BAN2401 will be effective at early stages of Alzheimer’s disease prior to significant neurodegeneration caused by amyloid deposits. It is hoped that treatment with BAN2401 and attempts to slow disease progression should be most effective at this early stage. As a site, the clinical research department at Abington Neurological Associates began work on this study in 2013 and is currently in the open-label extension phase. Enrollment is currently closed to new subjects.

Etheral — Alzheimer’s disease

Testing the Safety and Preliminary Efficacy of the New Drug ORY-2001 in Mild to Moderate Alzheimer’s Disease (ETHERAL-US)
This is a double-blind study designed to assess the safety and tolerability of two doses of ORY-2001 and placebo in patients with mild to moderate Alzheimer’s disease. ORY-2001 is a novel chemical entity developed as a drug for the treatment of cognitive decline in neurodegenerative diseases. Unlike most trials conducted by the clinical research department at Abington Neurological Associates that target Amyloid plaques and tau proteins, this trial aims to target the LSD1 and AMO-B proteins. The trial duration is 24 weeks for the double-blind period and 24 weeks for open-label extension.

S-Citad — Alzheimer’s disease

Escitalopram for Agitation in Alzheimer’s Disease (S-CitAD)
S-Citad is a 24-week trial designed to observe the efficacy and safety of escitalopram in combination with a psychosocial intervention (PSI) as treatment for Alzheimer’s patients experiencing agitation. Escitalopram is already approved to treat depression and anxiety. This study is currently enrolling new patients from real world settings such as outpatient and assisted living facilities.

T2 Protect AD — Alzheimer’s disease

Study of BHV-4157 in Alzheimer’s Disease (T2 Protect AD)
Riluzole is a glutamate blocker that is being investigated as a potential therapeutic benefit in Alzheimer’s disease. Riluzole has been documented to have a wide range of pharmacological actions, including interactions with several types of ion channels, cellular signaling mechanisms, and facilitation of glutamate reuptake. The T2 trial studying Riluzole, has been enrolling since early 2018 with patients entering a 48-week treatment phase followed by a 4-week follow up.

TRAILBLAZER-ALZ — Alzheimer’s disease

A Study of LY3002813 in Participants With Early Symptomatic Alzheimer’s Disease (TRAILBLAZER-ALZ)
LY3002813 is a plaque-specific monoclonal antibody being investigated in the I5T-MC-AACG clinical trial at ANA. The mechanism of action of Ly3002813 is considered to be the targeting and removal of the existing plaques, which is key to the pathological hallmark of Alzheimer’s disease. The trial is a double-blind, placebo-controlled study with no open–label extension period. It began in 2017 and is expected to end. It is no longer enrolling subjects.

TRAILBLAZER-ALZ 2 — Alzheimer’s disease

A Study of Donanemab (LY3002813) in Participants With Early Alzheimer’s Disease (TRAILBLAZER-ALZ 2)
Donanmab, also known as LY3002813, is a plaque-specific monoclonal antibody being investigated in the 15T-MC-AACI Clinical Trial at ANA. The mechanism of action of donanemab antibody is to target and remove deposited amyloid plaque, a key pathological hallmark of Alzheimer’s Disease, via microglial-mediated clearance. The trial is a double-blind, placebo-controlled study that takes place over 133 weeks.

Presence — Lewy body dementia

A Study of LY3154207 in Participants With Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson’s Disease (PD) or Dementia With Lewy Bodies (DLB) (PRESENCE)
LY3154207 has been examined in both healthy subjects and subjects with Parkinson’s disease. Results of examination suggest that LY3154207 has potentially beneficial effects on cognition and motor function, as well promoting wakefulness in sleep-deprived healthy adults. This study compares 3 doses of LY3154207 with placebo over 12 weeks in patients with mild to moderate dementia associated with Parkinson’s. This study is currently enrolling.

Allergan 301/303/309 — Migraines

There are currently 3 migraine trials being conducted at ANA. Allergan 301 and Allergan 309 are double-blind studies that evaluate the efficacy, safety, and tolerability of oral atogepant for the prevention of migraines in participants with episodic migraines. Atogepant is an oral CGRP (which stands for Calcitonin Gene-Related Peptide) receptor antagonist under investigation for migraine treatment. CGRP is a neuropeptide, found during migraine pain. It is thought that interrupting CGRP will interrupt the migraine pain and give people relief. The 301 study is a 20 week long, 8 visit clinical research trial, which requires patients to complete daily at-home migraine questionnaires. The 309 Trial is the open-label portion of the trial with a total of 12 visits. Allergan 303 is the 3rd trial investigating the same drug, atogepant, but for patients with chronic migraines. This study is a 20 week long, 8 visit clinical research trial, which requires patients to complete daily at-home migraine questionnaires. There are three dosing groups, which includes one placebo group.

Affinity — Multiple sclerosis

Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) (AFFINITY)
BIIB033 is a human monoclonal antibody directed against LINGO-1. This study hypothesizes that BIIB033 will act to block LINGO-1 in the central nervous system (CNS), promoting remyelination and axonal regeneration. It is hoped that this treatment in a demyelinating disease such as multiple sclerosis may result in improved CNS repair with additional beneficial effects on general neurological function and disability. This double-blind with open-label extension clinical trial has met their enrollment criteria and is not accepting new subjects.

Biogen 231MS201 — Multiple sclerosis

Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-β1) in Relapsing Multiple Sclerosis (RMS)
The proposed study (231MS201) will investigate the efficacy and safety of BIIB061 over72 weeks of treatment as an add-on therapy in adult participants with relapsing MS (RMS) who are on a stable dose of an anti-inflammatory disease modifying therapies (DMT) as compared to background anti-inflammatory DMT alone like interferon-beta1 (IFN-β1) products (Avonex, Plegridy, Betaferon/Betaseron, Extavia, and Rebif).

Currently approved MS DMTs effectively reduce the risk of relapse via their anti-inflammatory and immunomodulatory actions. However, no MS treatment has demonstrated enhancing/triggering remyelination. BIIB061 is a first-in-class, small molecule antagonist of S1P4 (a receptor protein), to aid Oligodendrocytes (myelinating cells) in remyelination of damaged neurons. BIIB061’s unique mechanism of action as an S1P4 antagonist may provide a pharmacological intervention to overcome the failure of remyelination in all forms of MS.

Exchange — Relapsing multiple sclerosis

Safety and Tolerability of Conversion From Oral or Injectable Disease Modifying Therapies to Dose-titrated Oral Siponimod in Advancing RMS Patients. (EXCHANGE)
This is a 6-month open-label, multi-center Phase IIIb study exploring the safety and tolerability of conversion from oral or injectable disease modifying therapies to dose-titrated oral Siponimod in patients with progressing forms of relapsing multiple sclerosis. It is hoped that the results of this study will provide healthcare providers with clinically relevant data necessary to inform clinically relevant decisions related to the transition from frequently used RMS DMTs to siponimod. Enrollment is currently open to new subjects.

MS200527_0080 — Multiple sclerosis

The purpose of this study is to characterize the efficacy and safety of evobrutinib 45 mg orally twice daily versus teriflunomide 14 mg once a day orally in participants with relapsing multiple sclerosis. Evobrutinib is a potent irreversible inhibitor of B cell activation. Additionally, evobrutinib inhibits the differentiation of proinflammatory macrophages, thus making it a suitable treatment of multiple sclerosis. The main study is double blinded and lasts 96 weeks after which participants will be eligible for the optional open label extension.

Opera/Veloce — Multiple sclerosis

Ocrelizumab is a humanized anti-CD20 monoclonal antibody. CD20 is the marker on B lymphocytes which are responsible in the immune response of human body. In Multiple sclerosis patient’s immune response mistakenly turns against the myelin sheath (fatty covering of neurons helpful in proper signaling) of neurons in Central nervous system. This results in the inflammatory response and ultimate destruction of the myelin sheath causing disruption of the normal signaling mechanism. Ocrelizumab targets CD20 marker on B lymphocytes and hence is an immunosuppressive drug as it suppresses B-lymphocytes and deny them the ability to disrupt the myelin sheath. Ocrelizumab’s is currently approved by FDA since March 2017. Its efficacy and risk benefit assessment is being conducted via two trials (Opera and Veloce), both Phase 3, by Hoffman-La Roche. These trials are currently closed to enrollment and have played an essential role in the collection of data for efficacy and safety of Ocrelizumab in patients of Multiple Sclerosis.

Boundless — Parkinson’s disease

A Clinical Trial Investigating the Efficacy, Safety and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson’s Disease Experiencing Motor Fluctuations (BouNDless)
ND0612 is being developed for patients who are responsive to Levodopa but, are not satisfied with the debilitating motor fluctuations of hyper/dyskinesia. NeuroDerm is conducting a clinical trial with a Levodopa/Carbidopa solution, in which the patient receives a continuous subcutaneous (SC) administration via an infusion pump system for the treatment of idiopathic PD. The trial is a double-blind trial with an optional open-label extension period, totaling in 92 weeks per trial subject. This trial is currently open to enrollment.

Glide — Parkinson’s disease

A Study to Assess the Safety and Effectiveness of Pridopidine Compared to Placebo in the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson’s Disease (gLIDe)
The main goal behind the Prilenia trial is to reduce dyskinesia in Parkinson’s patients. Levodopa dosage is one of the main risk factors for the development of dyskinesia. Pridopidine may fulfill an unmet need in the treatment of dyskinesia based on preclinical studies. This study supports the ability of pridopidine to reduce PD-LID without causing an adverse effect on Parkinsonian features. Prilenia is currently enrolling patients for an 18 week participation period.