A Study of PRX-03140 in Subjects With Alzheimer's Disease Receiving a Stable Dose of Donepezil

Epix Pharmaceuticals

Status and phase

Terminated

Phase 2

Conditions

Alzheimer's Disease

Treatments

Drug: Placebo

Drug: PRX-03140

Study type

Interventional

Funder types

Industry

Identifiers

NCT00672945

Protocol 01340-202

Details and patient eligibility

About

A randomized placebo-controlled study to evaluate the efficacy of PRX-03140 in subjects with Alzheimer's Disease receiving a stable dose of donepezil. The study consists of a 26-week double-blind treatment period.

Enrollment

420 estimated patients

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Men or Women with a clinical diagnosis of Probable AD
MMSE score 12 to 22 inclusive
Age >50 and <90 years
Received at least 4 months of a stable dose of donepezil 10mg QD for AD
Brain CT or MRI scan Consistent with a primary diagnosis of AD within 24 months
Neurological examination without focal deficits (excluding changes attributable to peripheral nervous system disease, trauma or congenital birth deficits)
No history or evidence of any other CNS disorder that could be interpreted as a cause of dementia
No diagnosis of vascular dementia
No history of significant psychiatric illness such as schizophrenia or bipolar affective disorder. Subjects with major depressive disorder on a stable dose of an antidepressant for >6 months may be eligible
No evidence of the following: current vitamin B12 deficiency, positive syphilis serology, positive HIV test, or abnormalities in thyroid function
No cognitive rehabilitation within 6 months of the study
Subject has a regular caregiver willing to attend all study visits
Signed informed consent by the subject (and legal guardian, if applicable)
No history of drug or alcohol abuse
No clinically significant laboratory abnormalities or medical history
No investigational drug within 30 days of Randomization
Cannot receive memantine within 2 months of enrollment
No other prescription acetylcholinesterase inhibitors for AD (other than donepezil) within 4 months of enrollment
No clinically significant ECG abnormalities or cardiac history
No history of uncontrolled seizure disorder within 12 months of enrollment
Cannot be taking MAO inhibitors, bupropion,fluoxetine, paroxetine, quinidine
No history of malignancy within 3 years of randomization
Women cannot be pregnant or breastfeeding