Last updated on April 2013

A Placebo-controlled, Double-blind, Parallel-group, Bayesian Adaptive Randomization Design and Dose Regimen-finding Study to Evaluate Safety, Tolerability and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease


Brief description of study

A Placebo-controlled, Double-blind, Parallel-group, Bayesian Adaptive Randomization Design and Dose Regimen-finding Study to Evaluate Safety, Tolerability and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease

Detailed Study Description

Patient Inclusion Criteria:

  • Ages: over 50-90
  • Male/Female
  • 90 week Long Clinical Trial
  • MMSE score 22-30
  • Positive amyloid load as indicated by PET assessment
  • Age between 50 and 90 years, inclusive
  • MMSE score equal to or greater than 22, and equal to or less than 30, at Screening and Baseline
  • BMI less than 35 at Screening
  • Females must not be pregnant or lactating, and specified contraceptive precautions must be followed
  • Subjects on acetylcholinesterase inhibitor or memantine therapy for Alzheimer's disease must be on a stable dose for at least 12 weeks prior to baseline
  • Subjects must have identified caregivers/informants
  • Subjects must provide written informed consent.

Patient Exclusion Criteria:

  • Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the subject's AD
  • History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening
  • Any psychiatric diagnosis or symptoms, (e.g., hallucinations, major depression, or delusions) that could interfere with study procedures in the subject
  • Contraindications to MRI scanning, including cardiac pacemaker/ defibrillator, ferromagnetic metal implants, e,g., in skull and cardiac devices other than those approved as safe for use in MR scanners
  • Evidence of other clinically significant lesions that could indicate a dementia diagnosis other than AD on brain MRI at Screening, or other significant pathological findings on brain MRI at Screening
  • A prolonged QT/QTc interval (QTc > 450 ms) as demonstrated by a repeated electrocardiogram (ECG)
  • Certain other specified medical conditions
  • Severe visual or hearing impairment that would prevent the subject from performing psychometric tests accurately

Clinical Study Identifier: TX136823

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Axiom Clinical Research of Florida

2919 Swann Ave, Suite 105A Tampa, FL USA
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Recruitment Status: Open


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