Trial Search Results

A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease

The purpose of this study is to determine the effects of CNP520 on cognition, global clinical status, and underlying AD pathology, as well as the safety of CNP520, in people at risk for the onset of clinical symptoms of AD based on their age, APOE genotype and elevated amyloid.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Novartis Pharmaceuticals

Collaborator: Banner Alzheimer's Institute

Stanford Investigator(s):

Intervention(s):

  • Drug: CNP520 50mg
  • Drug: CNP520 15mg
  • Other: Placebo to CNP520

Phase:

Phase 2/Phase 3

Eligibility


Inclusion Criteria:

   - consent to receive disclosure of their risk estimates to develop clinical symptoms of
   AD based on their APOE genotype and, if Heterozygotes, evidence of elevated brain
   amyloid.

   - Male or female, age 60 to 75 years inclusive. Females must be considered
   post-menopausal and not of child bearing potential

   - Cognitively unimpaired as evaluated by memory tests performed at screening.

   - Participant's willingness to have a study partner.

   - Carrier of at least one APOE4 gene if Heterozygotes, elevated brain amyloid (as
   measured by CSF Abeta or amyloid PET imaging).

Exclusion Criteria:

   - Any disability that may prevent the participants from completing all study
   requirements. -

   - Current medical or neurological condition that might impact cognition or performance
   on cognitive assessments.

   - Advanced, severe progressive or unstable disease that may interfere with the safety,
   tolerability and study assessments, or put the participant at special risk.

   - History of malignancy of any organ system, treated or untreated, within the past 60
   months.

   - Indication for, or current treatment with ChEIs and/or another AD treatment (e.g.
   memantine).

   - Contraindication or intolerance to MRI.

   - Brain MRI results showing findings unrelated to AD that, in the opinion of the
   Investigator might be a leading cause to future cognitive decline, might pose a risk
   to the participant, or might prevent a satisfactory MRI assessment for safety
   monitoring.

   - Suicidal Ideation in the past six months, or Suicidal Behavior in the past two years.

   - A positive drug screen at Screening, if, in the Investigator's opinion, this is due to
   drug abuse.

   - Significantly abnormal laboratory results at Screening, not as a result of a temporary
   condition.

   - Current clinically significant ECG findings.

   - Clinically relevant depigmenting or hypopigmenting conditions (e.g. albinism,
   vitiligo) or active / history of chronic urticaria in the past year.

Ages Eligible for Study

60 Years - 75 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting