Lakewood, Ohio Clinical Trials

The name of this trial is MissionAD1. This 24-month treatment, multicenter, double-blind, placebo-controlled, parallel group, Phase 3 study in participants with Early Alzheimer's Disease (EAD) including mild cognitive impairment (MCI) due to Alzheimer's Disease (AD)/Prodromal AD and the early stages of mild AD will be conducted to evaluate the efficacy ...

Eligible participants for this study must have a diagnosis of probable AD and must have clinically meaningful agitation secondary to AD. This is a multicenter, randomized, placebo-controlled study, consisting of 12 weeks of treatment. Approximately 470 participants will be enrolled at approximately 75 centers in North America. Study medication will ...

Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, or 12-AVR-131. Participants will be enrolled in the study for approximately 56 weeks (participants who have a follow-up visit 3 months after the last dose of treatment will be enrolled for approximately 64 weeks). Approximately 700 participants will be enrolled at approximately 135 ...

The proposed investigation is designed to solicit a large number of patients (N=1,500) with non-healing wounds (Diabetic Foot Ulcers, Venous Ulcers, or Pressure Ulcers) that have not responded to standard wound care in the previous 30 days or more. A prospective, interventional, single-blinded, controlled, registry trial will be used. Data ...

This study will be conducted to compare E2027 to placebo on the cognitive endpoint of Montreal Cognitive Assessment (MoCA) and the global clinical endpoint of Clinician's Interview Based Impression of Change Plus (CIBIC-Plus) Caregiver Input in participants with dementia with Lewy bodies after 12 weeks of treatment.

A Phase 3b, single arm, open-label, multicenter study in treatment nave adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of ...

This is a Phase III, multicenter, open-label, randomized study designed to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab compared with pembrolizumab in treatment-naive participants with advanced BRAFV600 wild-type melanoma.

PRIMARY OBJECTIVES: I. To determine the effect of maintenance obinutuzumab on duration of complete response (CR) in patients with CD20+ B-cell primary central nervous system lymphoma (PCNSL) who attain CR to first-line treatment with high-dose methotrexate-based chemotherapy. SECONDARY OBJECTIVES: I. To evaluate overall survival after CR (overall survival [OS]-CR). II. ...

OUTLINE: This is a 2-part, multicenter, randomized study. Patients are stratified according to gender, weight loss 6 months prior to study entry ( 5% of body weight vs > 5% of body weight), ECOG performance status (0 vs 1 vs 2), radiotherapy technique (intensity-modulated radiotherapy vs 3-dimensional conformal radiotherapy), radiotherapy ...

PRIMARY OBJECTIVES: I. To evaluate the overall response rate (ORR) (confirmed and unconfirmed, complete and partial) with talazoparib (BMN 673) in HRRD Medivation (MDVN)-positive patients. SECONDARY OBJECTIVES: I. To evaluate investigator assessed progression-free survival (IA-PFS) and overall survival (OS) associated with therapy in HRRD MDVN-positive patients. II. To evaluate ORR, ...