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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 August 2021
• Main ID: NCT03131453
• Date of registration: 05/04/2017
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease GS2
• Scientific title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CNP520 in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease (AD).
• Date of first enrolment: August 3, 2017
• Target sample size: 1145
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03131453
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Canada, Chile, China, Finland, France, Germany, Iceland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Portugal, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Taiwan, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

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 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.



Age minimum: 60 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Alzheimers Disease

Intervention(s)

Drug: CNP520 50mg

Other: Matching placebo

Drug: CNP520 15mg

Primary Outcome(s)

Time to Event (Diagnosis of Mild Cognitive Impairment or Dementia, Due to Alzheimer's Disease (AD)) [Time Frame: Baseline to last cognitive assessment performed (up to day 648)]

Change in the Alzheimer's Prevention Initiative Composite Cognitive (APCC) Test Score [Time Frame: Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)]

Secondary Outcome(s)

Annualized Percent Change on Volume of Brain Regions [Time Frame: Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)]

Change in CSF Levels of Amyloid Beta 42 (Aß42) [Time Frame: Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)]

Change in the Everyday Cognition Scale (ECog-Informant) Total Scores [Time Frame: Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)]

Change in the Total and Index Scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [Time Frame: Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)]

Change in Amyloid Deposition as Measured by Standardized Uptake Ratio (SUVR) of Positron Emission Tomography (PET) Scan With Amyloid Radiotracer [Time Frame: Baseline to Months 24 and 60]

Change in CSF Levels of Total Tau and Phosphorylated Tau [Time Frame: Baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648)]

Change in Neurofibrillary Tangle Burden as Measured by Standardized Uptake Ratio (SUVR) of PET Scans With Tau Radiotracer (Where Available) [Time Frame: Baseline to Months 24 and 60]

Change in CSF Levels of Amyloid Beta 40 (Aß40) [Time Frame: Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)]

Change in Serum Neurofilaments [Time Frame: Baseline to Week 26, baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648)]

Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Score [Time Frame: Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)]

Change in the Everyday Cognition Scale (ECog-Subject) Total Scores [Time Frame: Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)]

Number of Participants With Newly Occurring Safety MRI Abnormalities (ARIA-E, ARIA-H,White Matter Disease and Any Other MRI Abnormalities) [Time Frame: Baseline up to study termination approximately 617 days]

Number of Suicidal Ideation or Behavior Events [Time Frame: Baseline up to study termination approximately 617 days]

Secondary ID(s)

CCNP520A2202J

2016-002976-28

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Banner Alzheimer's Institute

Amgen

Results

• Results available: Yes
• Date Posted: 05/08/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03131453