KHK6640 Phase I study (A single dose study in patients with Alzheimer's disease)
- Conditions
- Alzheimer's disease
- Registration Number
- JPRN-jRCT2080222766
- Lead Sponsor
- Kyowa Hakko Kirin Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 20
Patients with mild to moderate AD
- Body weight >= 40 kg and < 100 kg
- CDR score of 1 or 2
- MMSE score of >= 17 and =< 26
- Previous active treatment with an AD immunotherapy in an investigational study
- Use of another investigational drug within 4 months prior to the enrollment
- Subjects who meet National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
- Subjects with a history of presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease
- Subjects who have evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than AD
- Subjects with a presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's AD
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety<br>Safety (adverse events)
- Secondary Outcome Measures
Name Time Method