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A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of PRX-03140 as Monotherapy in Subjects With Alzheimer's Disease

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Trial Conditions
  • Alzheimer's Disease
What is the purpose of this trial?

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.

Date & Status

Terminated

Who can Participate?

Eligibility

Ages:
50  - 90 

Gender:
Both

Eligibility

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

Gender: Both
Trial Interventions
Drug
  • PRX-03140
  • Donepezil
  • Placebo
Other Information

Sponsor: Epix Pharmaceuticals, Inc.
Phase: Phase 2
Trial ID: NCT00693004
Volunteers:  Not Accepting Healthy Volunteers

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