Effect of Gantenerumab on amyloid PET SUVr in patients with early Alzheimer's disease (AD)
Phase 2
Completed
- Conditions
- ALZHEIMER'S DISEASE
- Registration Number
- JPRN-jRCT2080224569
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Evidence of amyloid pathology as indicated by a positive result on central reading of an amyloid PET scan using flutemetamol (18F)
- Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical criteria for probable AD dementia or prodromal AD (consistent with the NIAAA diagnostic criteria and guidelines for mild cognitive impairment)
- MMSE score greater than or equal to 22
- CDR-Global score of 0.5 or 1.0
Exclusion Criteria
- Any evidence of a condition other than AD that may affect cognition
- History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder
- History or presence of clinically evident cerebrovascular disease
- ARIA-E or any other significant cerebral abnormalities
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pharmacodynamics<br>Observation/examination
- Secondary Outcome Measures
Name Time Method efficacy<br>Observation/examination