Study of the Pharmacokinetics and Pharmacodynamics of POSIPHEN® in Subjects With Amnestic Mild Cognitive Impairment
|ClinicalTrials.gov Identifier: NCT01072812|
Recruitment Status : Terminated (Business decision based on funding)
First Posted : February 22, 2010
Last Update Posted : April 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Amnestic Mild Cognitive Impairment||Drug: Posiphen® tartrate capsules||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Two-Stage Study to Evaluate the Pharmacokinetics and Pharmacodynamics of POSIPHEN® in Plasma and CSF After a 10-Day Treatment Period in Subjects With Amnestic Mild Cognitive Impairment|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
|Experimental: Posiphen® tartrate capsules||
Drug: Posiphen® tartrate capsules
Capsules administered (240 mg/day) for 10 days Capsules administered (160 mg/day) for 10 days
Other Name: Posiphen® Tartrate
- Pharmacokinetics [ Time Frame: 10 days ]To determine the pharmacokinetics (PK) of Posiphen® and its metabolites in plasma and CSF after a 10-day treatment period with Posiphen®.
- Pharmacodynamics [ Time Frame: 10 days ]To assess the effects of a 10-day treatment period with Posiphen® on the levels of amyloid precursor protein (APP), amyloid β protein 40 (Aβ40), amyloid β protein 42 (Aβ42), acetylcholinesterase (AChE), and butyrylcholinesterase (BChE) in plasma and CSF from subjects with amnestic MCI.
- Biomarkers [ Time Frame: 10 days ]To assess the effects of a 10-day treatment period with Posiphen® on the levels of amino terminal fragment (N-APP), tau (T-tau), phosphorylated tau (P-tau), nerve growth factor (NGF), brain derived neurotrophic factor (BDNF), interleukin 1B (IL1B), S-100B protein (S-100B) in plasma or serum and CSF, and the activities of AChE and BChE in whole blood or plasma and CSF from subjects with amnestic MCI.
- Safety [ Time Frame: 10 days ]To determine the safety and tolerability of a 10-day treatment period with Posiphen®.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01072812
|United States, Texas|
|CEDRA Clinical Research, LLC|
|San Antonio, Texas, United States, 78217|
|Principal Investigator:||Mark T Leibowitz, MD||CEDRA|