Study of the Pharmacokinetics and Pharmacodynamics of POSIPHEN® in Subjects With Amnestic Mild Cognitive Impairment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Primary Completion Date :||July 2010|
|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®.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|