NCT03131453 · Phase 2 · TERMINATED
A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease
This trial tested CNP520, a drug designed to reduce amyloid buildup in the brain, against a placebo in cognitively normal older adults at elevated risk for Alzheimer's symptoms. Researchers measured effects on cognition, clinical status, and brain amyloid levels. This was a Phase 2 trial, meaning it was evaluating whether the drug worked and was safe — it was not a proven or approved treatment. Note: this trial has since been stopped early due to unexpected cognitive side effects.
You may qualify if
- 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).
You're excluded if
- Any disability that could have prevented the participants from completing all study requirements. -
- Current medical or neurological condition that could have impacted cognition or performance on cognitive assessments.
- Advanced, severe progressive or unstable disease that could have interfered 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, could have posed a risk to the participant, or could have prevented 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, was 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2021-08-05