Study of PRX-03140 Monotherapy in Subjects With Alzheimer's Disease

Epix Pharmaceuticals

Status and phase

Terminated

Phase 2

Conditions

Alzheimer's Disease

Treatments

Drug: Placebo

Drug: Donepezil

Drug: PRX-03140

Study type

Interventional

Funder types

Industry

Identifiers

NCT00693004

Protocol 03140-203

Details and patient eligibility

About

A randomized placebo-controlled study to evaluate the efficacy of PRX-03140 monotherapy in subjects with Alzheimer's disease. The study consists of a 3-month double-blind treatment period and an optional 3-month extension period.

Enrollment

236 estimated patients

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Men or Women with a clinical diagnosis of Probable AD
MMSE score 16 to 24 inclusive
Age >50 and <90 years
Brain CT or MRI scan Consistent with a primary diagnosis of AD within 12 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)

Exclusion criteria

No history of drug or alcohol abuse
No clinically significant laboratory abnormalities or medical history
No investigational drug within 30 days of Randomization
Intolerance or allergy to cholinesterase inhibitors
Cannot have been on cholinesterase inhibitors for AD for > 2 years
If have been on cholinesterase inhibitors for < 2 years, must have been discontinued >= 2 months prior to randomization
Cannot have received memantine within 2 months
No clinically significant ECG abnormalities prior to randomization
No history of uncontrolled seizure disorder within 12 months
Cannot be taking MAO inhibitors, bupropion,fluoxetine, paroxetine, quinidine
No history of malignancy within 3 years of randomization
Women cannot be pregnant or breastfeeding