Alzheimer's Disease

A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

Inclusion Criteria:

  • Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months

  • MMSE score of 20 to 28 (inclusive) at baseline

  • Meet 18F flortaucipir PET scan (central read) criteria

  • Meet 18F florbetapir PET scan (central read) criteria

  • Have a study partner who will provide written informed consent to participate

Exclusion Criteria:

  • Contraindication to MRI or PET scans

  • Current treatment with immunoglobulin G (IgG) therapy

ASTHMA

 

A Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Assess the Safety, Efficacy and Pharmacodynamics of TEV 53275 Administered Subcutaneously in Adult Patients With Persistent Eosinophilic Asthma

The total duration of study participation is approximately 34 weeks including up to a 2-week screening period, a 2-week run-in period, a 16-week treatment period, and a follow-up visit 14 weeks after the final treatment visit.

You may be eligible if you are:

  •   18 years of age and Up

  •   Currently using a daily maintenance inhaled steroid

  •   Able to attend 10 visits over 34 weeks

  •   A non-smoker for 1 year with limited smoking history

*Additional criteria may apply

There is no cost to participate and no insurance is required.  All study-related care and investigational study-drug are provided at no cost.  You may be compensated for your time and travel.

Please call 215-884-1700 to speak with Dr. Kalafer

Agitation in Subjects with Dementia of Alzheimer's Type

A Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer's Type Actual Study Start Date  :December 31, 2020

 

Enrolled patients will first enter a 9-week, open-label stabilization period, during which they will be treated with AXS-05 and monitored for a treatment response. Patients who experience a treatment response during the stabilization period will then be randomized into the double-blind treatment period, in a 1:1 ratio, to continue treatment with AXS-05 or to switch to placebo, for up to 26 weeks or until a relapse of agitation occurs.

Inclusion Criteria:

  • Diagnosis of probable Alzheimer's disease (AD) based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria.

  • Diagnosis of clinically signification agitation resulting from probable AD according to the International Psychogeriatric Association (IPA) provisional definition of agitation.

Exclusion Criteria:

  • Patient has dementia predominantly of non-Alzheimer's type.

  • Patient has symptoms of agitation that are not secondary to AD (e.g., pain, other psychiatric disorder or delirium due to a metabolic disorder, systemic infection, or substance-induced).

  • Unable to comply with study procedures.

  • Medically inappropriate for study participation in the opinion of the investigator.

COPD (Chronic Obstructive pulmonary disease)

A Phase III Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD (TRITON)

Ages Eligible for Study:  40 Years and older  

 

Inclusion Criteria:

  • Signed and dated written informed consent must be obtained prior to initiating any study-related procedures

  • Outpatient

  • Male or female subjects aged ≥40 years

  • COPD diagnosis for at least 12 months before the screening visit in accordance with the definition by the GOLD 2020 Report

 

Exclusion Criteria:

  • Female subjects who are pregnant (as evident by a positive urine hCG or serum β-hCG test) or lactating

  • Current treatment with non-cardioselective β-blockers

  • Requirement of long term (> 15 hours daily) oxygen therapy

Alzheimer's Disease 

This Phase 3, 36-month study (41 office visits) assesses the safety and efficacy of gantenerumab in patients with early, prodromal to mild Alzheimer's disease. 

Inclusion/Exclusion Criteria:

  • Males or Females 50-90 years old at screening.

  • Evidence of AD pathological process as confirmed by amyloid PET scan or CSF Tau.

  • Demonstrate abnormal memory functions during testing at screening.

  • Has an available study partner (a person who has frequent and sufficient contact with the patient).

Stress Urinary Incontinence 

Pursuit- Prospective US Radiofrequency SUI trial is for premenopausal women who leak urine during certain activities, including exercising, laughing, coughing, sneezing or other physical activities related to stress urinary incontinence (SUI)

Inclusion Criteria:

  • Pre-menopausal females, ≥ 18 years of age. Premenopausal is defined as a woman who has had menstrual cycles over the previous 12 months.

  • Subjects with a BMI of ≤ 35 kg/m².

Exclusion Criteria:

  • Subjects who are currently breastfeeding or have discontinued breastfeeding fewer than 6 months prior to screening.

  • Subjects who are pregnant or plan to become pregnant during the course of the study.

  • Subjects who have undergone other stress urinary incontinence treatments, excluding behavioral modifications (e.g., Kegel exercises).

  • Has any implantable electrical device [e.g., implantable pacemaker, automatic implantable cardioverter-defibrillator (AICD)].

Treatment Resistant Hypertension

A Phase 3, Double-blind, Placebo-controlled, Efficacy and Safety Study of Firibastat (QGC001) Administered Orally, Twice Daily, Over 12 Weeks in Difficult-to-treat/Resistant Hypertensive Subjects

Ages Eligible for Study:  18 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:  All

Inclusion Criteria:

  • Men and women ≥18 years of age at Screening

  • Diagnosis of primary HTN for at least 6 months prior to Screening

Exclusion Criteria:

  • Known or suspected secondary HTN (eg, hyperaldosteronism, renovascular HTN, pheochromocytoma, Cushing's disease).

  • Automated office SBP >170 mmHg or DBP >110 mmHg at the Screening or Inclusion Visit (Visit 2, Day 1) and confirmed by a second measurement within 30 minutes to 1 hour.

  • Known hypertensive retinopathy (Keith-Wagener Grade 3 or Grade 4) and/or hypertensive encephalopathy.

This is a double-blind, placebo-controlled, multicenter, efficacy and safety study of firibastat (QGC001) administered po bid over 12 weeks in male and female subjects ≥18 years of age at Screening, with uncontrolled primary HTN. Subjects will be randomized 1:1 to investigational product (IP) and will receive either firibastat (QGC001) or matching placebo on top of their current chronic antihypertensive treatments.

Post Herpetic Neuralgia ( Post Shingles pain)

A Phase 2, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of LX9211 in the Treatment of Postherpetic Neuralgia (RELIEF-PHN1)

Inclusion Criteria:

  • Patient has given written informed consent to participate in the study in accordance with local regulations

  • Adult male and female patients ≥18 years of age at the time of screening

  • PHN pain that is present for ≥3 months after healing of herpes zoster skin rash affecting a single dermatome (Patients with more than 1 involved dermatome may also be included, provided the affected dermatomes are contiguous)

  • Moderate to severe pain as confirmed by average pain score using scores recorded in the pain diary in the 14 days prior to randomization

Exclusion Criteria:

  • Presence of other painful conditions that may confound assessment or self-evaluation of PHN

  • History of major depressive episode, active, significant psychiatric disorders

  • History of clinically significant drug or alcohol use disorder

  • PHN affecting the face

  • Use of opioid medications for management of PHN within the 2 months prior to Screening Visit

  • Use of NSAIDs for the specific treatment of PHN pain