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

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    Recruiting
Updated on 8 December 2020

Summary

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

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

Details
Clinical Study IdentifierTX136823
Last Modified on8 December 2020

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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