Pharmanet

Study:

A double-blind, Phase II, placebo-controlled trial to evaluate the safety and efficacy of a novel compound in subjects with mild-to-moderate Alzheimer’s disease. More than 630 subjects were enrolled at more than 80 sites in the US and Canada.

Services Provided:

Project management, clinical monitoring, site management, vendor management, medical monitoring, pharmacovigilance, data management, regulatory review, and medical writing.

Challenges:

First, to develop a recruitment strategy that addressed two significant enrollment issues:

	The FDA had recently approved a similar Alzheimer’s medication (Namenda)
The trial protocol contained strict concomitant-medication requirements

Second, to maintain high levels of compliance and retention of both study participants and their caregivers for the 13-month duration of the study.

Solutions:

The Neuroscience team worked closely with PharmaNet’s Clinical Recruitment Group to identify and attract a difficult subject population.

The team then created a program to increase subject retention by providing caregivers with valuable information to help them understand and care for their loved ones. The program also expressed appreciation for the caregivers‘ dedication to the trial.

The team also provided site feedback and advice from PharmaNet’s medical staff to assist the client in evaluating the inclusion/exclusion criteria.

Outcome:

As a result of the Neuroscience team’s feedback and advice on inclusion/exclusion criteria, the client amended the protocol to improve both recruitment and retention.

The team’s thorough site training, accurate monitoring, and efficient data processing resulted in a consistently low query rate of 0.10 per CRF page.