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Completed

NCT Number: NCT00384423

Short Term Effects of PRX-03140 in Patients With Mild Alzheimer's Disease Being Treated With Aricept

This is a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRX-03140 administered orally once daily for 14 days in subjects with mild Alzheimer's Disease who are using a stable, well-tolerated 10 mg dose of Aricept (donepezil) but continue to experience worsening AD symptoms.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

California Clinical Trials Medical Group, Inc, Paramount, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 60 years old.
  • On a stable 10 mg dose of Aricept for at least 90 days and able to take it in the morning.
  • Diagnosis of probable Alzheimer's Disease.
  • Mild dementia.
  • You or your authorized representative provide voluntary written informed consent.
  • Not pregnant, planning a pregnancy, or capable of becoming pregnant.

Exclusion criteria

  • Any other medical condition which, in the opinion of the Investigator, would jeopardize your safety, impact the validity of the study results, or interfere with your ability to complete the study according to the protocol.
  • Intolerance to Aricept.
  • Dementia other than Alzheimer's type.
  • Parkinson's Disease.
  • History of seizure or epilepsy.
  • History of stroke.
  • Participation in another research study within last 30 days.
  • Enrollment in any previous research study testing PRX-03140.
  • Use of prescription cognitive enhancing medications (except Aricept) or MAO inhibitors within last 4 weeks.
  • Use of tobacco products within last 4 weeks.
  • Positive blood screen for Hepatitis B surface antigen or Hepatitis C antibody.
  • Positive urine screen for alcohol or drugs of abuse or history of drug or alcohol abuse within last 6 months.
  • Major surgery within last 4 weeks.

Treatment and study plan

PRX-03140

Drug

Primary outcomes

  1. Safety and tolerability of PRX-03140 during 2 weeks of treatment.

  2. Electroencephalogram (EEG) changes through 14 days of treatment.

Secondary outcomes

  1. Changes in cognition after 2 weeks of treatment.

  2. Blood concentrations of PRX-03140 and Aricept during 14 days of treatment.

Sponsors and collaborators

Lead sponsor

Epix Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Phase IIa Study to Assess the Short-Term Effects of PRX-03140 Alone and in Combination With Donepezil in Subjects With Mild Alzheimer's Disease.

Important dates

Study start
2006
Primary completion
2007
First posted
Oct 6, 2006
Registry last updated
Jan 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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