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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Alzheimers Disease

In brief

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.

Key facts

Study ID

NCT03131453

Run by

Novartis Pharmaceuticals

People needed

1145

Starts

2017-08-03

Expected to finish

2020-03-26

Last updated by the study team

2021-08-05

Who can join

Age: 60 and older, up to 75. Sex: any. Healthy volunteers: accepted.

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 may not qualify 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.

Where it is running

• Banner Sun Health Research Institute, 10515 West Santa Fe Drive, Building B — Sun City, Arizona, United States
• Novartis Investigative Site — Tucson, Arizona, United States
• ATP Clinical Research Inc, 3151 Airway Avenue T 3 — Costa Mesa, California, United States
• Irvine Center for Clinical Res, 2515 McCabe Way — Irvine, California, United States
• Torrance Clinical Research Institute, 25043 Narbonne Avenue — Lomita, California, United States
• Novartis Investigative Site — Oxnard, California, United States
• Novartis Investigative Site — Palo Alto, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Syrentis Clinical Research, 1401 N Tustin Ave, Suite 130 — Santa Ana, California, United States
• Novartis Investigative Site — Sebastopol, California, United States
• Novartis Investigative Site — Sherman Oaks, California, United States
• Mountain Neurological Research, 350 Market Street, Suite 316 — Basalt, Colorado, United States
• Colorado Springs Neurological, 2312 North Nevada Avenue, Suite 100 — Colorado Springs, Colorado, United States
• Denver Neurological Clinic, 950 E Harvard Ave — Denver, Colorado, United States
• Yale University, One Church Street, Suite 600 — New Haven, Connecticut, United States
• Novartis Investigative Site — Stamford, Connecticut, United States
• Novartis Investigative Site — Washington D.C., District of Columbia, United States
• Novartis Investigative Site — Atlantis, Florida, United States
• Quantum Laboratories — Deerfield Beach, Florida, United States
• Brain Matters Research, Inc., 800 NW 17th Avenue — Delray Beach, Florida, United States
• Infinity Clinical Research LLC, 4925 Sheridan Street, Suite 200 — Hollywood, Florida, United States
• Alzheimer's Research and Treatment Center, 5065 State Road 7, Suite 102 — Lake Worth, Florida, United States
• Meridien Research, 2300 Maitland center, Pkwy Ste 230 — Maitland, Florida, United States
• Novartis Investigative Site — Melbourne, Florida, United States
• Banner Alzheimer's Institute, 901 East Willetta Street — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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