Safety and Tolerability of GRF6019 Infusions in Severe Alzheimer's Disease: A Phase II Double-Blind Placebo-Controlled Trial.

Background: The plasma fraction GRF6019 shows multiple benefits on brain aging in mice, including enhanced cognition, neurogenesis, and synaptic density, as well as reduced neuroinflammation.

Objective: To evaluate the safety, tolerability, and preliminary efficacy of GRF6019 in patients with severe Alzheimer's disease (AD).

Methods: A phase II, double-blind, placebo-controlled study in patients with severe AD (Mini-Mental State Examination score 0-10).

Safety and tolerability of GRF6019 in mild-to-moderate Alzheimer's disease dementia.

Introduction: This phase 2 trial evaluated the safety, tolerability, and feasibility of repeated infusions of the plasma fraction GRF6019 in mild-to-moderate Alzheimer's disease.

Methods: In this randomized, double-blind, dose-comparison trial, 47 patients were randomized 1:1 to receive daily infusions of 100 mL (n = 24) or 250 mL (n = 23) of GRF6019 for 5 consecutive days over two dosing periods separated by a treatment-free interval of 3 months.

Results: The mean (standard deviation [SD]) age of the enrolled patients was 74.

Electrocardiographic and cardiovascular diagnostic characteristics of patients receiving long-term opioid therapy for pain.

Objective: To examine cardiovascular and electrocardiogram (ECG) abnormalities seen in patients with chronic pain receiving long-term opioid therapy and to compare them with findings in normal subjects.

Setting: Clinical pharmaceutical drug trial in a phase I pharmacology unit (normal subjects) and multiple phase 2b study sites (pain patients).

Patients: Four hundred sixty-one pain patients with constipation due to long-term opioid therapy who were screened for a clinical trial of an investigational treatment for opioid-induced constipation.

Efficacy and safety of an extended-release oxycodone (Remoxy) formulation in patients with moderate to severe osteoarthritic pain.

Objective: To evaluate the efficacy and safety of an encapsulated, highly viscous formulation of extended-release oxycodone designed to resist common physical manipulation and chemical challenges (Remoxy; King Pharmaceuticals, Inc., Bristol, TV, which was acquired by Pfizer Inc. in March 2011).

Long-term safety of Remoxy® (extended-release oxycodone) in patients with moderate to severe chronic osteoarthritis or low back pain.

Objective: Evaluate the long-term safety, tolerability, and efficacy of Remoxy® (extended-release oxycodone) in patients with chronic pain related to osteoarthritis of the hip and/or knee or chronic low back pain.

Design: Open-label, 12-month, phase 3 trial.

Setting: Fifty-nine US sites.