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Two new experimental Alzheimer’s drug trials now recruiting patient/caregiver teams in the U.S. – One in 30 locations and one in 28 locations

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By ProHealth.com • www.ProHealth.com • August 29, 2008


Two Phase II clinical research trials for an investigational Alzheimer's disease drug (PRX-03140) have just begun to recruit.

Target participation: more than 650 patients with clinical diagnosis of probable Alzheimer’s, or (for the second trial only) memory problems that may be a sign of Alzheimer’s.

The hope is to connect patients “with a medication that may make a difference in their functioning and quality of life” as measured by improvements in memory and cognitive function.

For information about the medication – PRX-03140 – and results of Phase 1 and Phase 2A trials, click here.

For broad patient/caregiver eligibility screening questions, see “Will my loved one qualify?” or call toll free 1-866-521-4455

* * * *

TRIAL 1: A 6-month trial evaluating PRX-03140 in patients with Alzheimer's disease who are also receiving a stable dose of donepezil (Aricept®)

Title & ClinicalTrials.gov ID #:
“A Study of PRX-03140 in Subjects With Alzheimer’s Disease Receiving a Stable Dose of Donepezil”
ID# NCT00672945

Target enrollment: 420, either sex. With partner to support participation.

Locations: Trial centers in 33 locations & 14 states (see ClinicalTrials.gov listing)

Ages: 50 to 90.

Other key qualifying criteria:
• Has a diagnosis of probable Alzheimer’s disease
• Has been on a stable dose of Aricept® (donepezil) for Alzheimer’s disease for at least three months
• Has no history of cancer within the past three years
• Is able to attend all office visits
• Lives with, or spends substantial periods of time with, a regular caregiver who is willing to attend all trial visits, oversee compliance, and report on the loved one’s status

For further information: contact Julia Kazakin, MD jkazakin@epixpharma.com 781/761-7646

* * * *

TRIAL 2: A trial evaluating PRX-03140 in patients with Alzheimer's disease who are not taking medication for the illness.

This will include a 3-month double blind treatment period, followed by an optional 3-month treatment period with all participants taking either PRX-03140 or donepezil (Aricept®).

Title & ClinicalTrials.gov ID #:
“Study of PRX-03140 Monotherapy in Subjects With Alzheimer’s Disease”
ID# NCT00693004

Target enrollment: 236, either sex. With partner to support participation.

Locations: Trial centers in 28 locations & 13 states (see ClinicalTrials.gov listing).

Ages: 50 to 90.

Other key qualifying criteria:
• Has a diagnosis of probable Alzheimer’s disease or has memory problems that may be a sign of Alzheimer’s disease
• Is not taking any medications for Alzheimer’s disease
• Has no history of cancer within the past three years
• Is able to attend all office visits
• Lives with, or spends substantial periods of time with, a regular caregiver who is willing to attend all trial visits, oversee compliance, and report on the loved one’s status.

For further information: Contact Julia Kazakin, MD jkazakin@epixpharma.com 781/761-7646

Both trials are being sponsored by EPIX Pharmaceuticals.

For more information about the trial such as frequently asked questions, trial center locations, and more, visit the trial website at http://www.trialforad.com.
___
Note: This information has not been evaluated by the FDA. It is generic and is not meant to prevent, diagnose, treat or cure any illness, condition, or disease. It is very important that you make no change in your healthcare plan or health support regimen without researching and discussing it in collaboration with your professional healthcare team.




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