Trial Search Results

A Study of CAD106 and CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease

The purpose of this study is to test whether two investigational drugs called CAD106 and CNP520, administered separately, can slow down the onset and progression of clinical symptoms associated with Alzheimer's disease (AD) in participants at the risk to develop clinical symptoms based on their age and genotype.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Novartis Pharmaceuticals

Collaborator: Amgen

Stanford Investigator(s):

Intervention(s):

  • Biological: CAD106 Immunotherapy
  • Other: Placebo to CAD106
  • Drug: CNP520
  • Other: Placebo to CNP520

Phase:

Phase 2/Phase 3

Eligibility


Key Inclusion Criteria:

   - Consent to receive disclosure of their risk estimates to develop clinical symptoms of
   AD based on their APOE genotype.

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

   - Mini-Mental State Examination (MMSE) total score ≥ 24 (at screening or in previous 3
   months) and cognitively unimpaired as evaluated by memory tests performed at
   screening.

   - Homozygous APOE4 genotype.

   - Participant's willingness to have a study partner.

Key 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.

   - History of hypersensitivity to any of the investigational drugs or their excipients /
   adjuvant or to drugs of similar chemical classes.

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

   - Contraindication or intolerance to MRI or PET investigations (with fluorinated radio
   ligands).

   - 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, or infection not as a result
   of a temporary condition.

   - Current clinically significant ECG findings. For Cohort - I only: Participants with
   previous organ transplantation or stem cell transplantation, or indication for
   treatment with anti-coagulants.

For Cohort - II only: Participants with depigmenting or hypopigmenting conditions (e.g.
albinism vitiligo) or active / history of chronic urticarial 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