Randomized I/II Phase Study of ALZT-OP1 Combination Therapy in Alzheimer's Disease and Normal Healthy Volunteers
Status:
Completed
Trial end date:
2021-01-18
Target enrollment:
Participant gender:
Summary
This is a randomized, open-label, cross-over, pharmacokinetic and pharmacodynamic PK/PD
study. (Part A)The PK portion of the study is designed to evaluate the pharmacokinetics of
ALZT-OP1 (a combination drug therapy) designated as ALZT-OP1a and ALZT-OP1b, in both plasma
and CSF, following co-administration of the two active investigational products, in healthy
volunteers and Alzheimer subjects aged 55-79 and in good health. (Part B) The PD portion of
the study will evaluate the pharmacodynamics of ALZT- OP1, using both plasma and CSF
biomarkers, following 60 days of consecutive daily treatment, in AD subjects only.