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

Phase 2 Double-Blind Study of PRX-03140 in Subjects With Alzheimer's Disease Receiving a Stable Dose of Donepezil

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00672945
Enrollment
420
Registered
2008-05-06
Start date
2008-04-30
Completion date
Unknown
Last updated
2009-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Brief summary

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.

Interventions

DRUGPlacebo

Sponsors

Epix Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Alzheimer's Disease Assessment Scale-Cognitive subscale.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026