Study of the Pharmacokinetics and Pharmacodynamics of POSIPHEN® in Subjects With Amnestic Mild Cognitive Impairment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by QR Pharma Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
QR Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01072812
First received: February 19, 2010
Last updated: June 11, 2011
Last verified: June 2011

February 19, 2010
June 11, 2011
February 2010
September 2011   (final data collection date for primary outcome measure)
  • Pharmacokinetics [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01072812 on ClinicalTrials.gov Archive Site
  • Biomarkers [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    To determine the safety and tolerability of a 10-day treatment period with Posiphen®.
Same as current
Not Provided
Not Provided
 
Study of the Pharmacokinetics and Pharmacodynamics of POSIPHEN® in Subjects With Amnestic Mild Cognitive Impairment
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

This trial will determine the pharmacokinetics of Posiphen® in both plasma and CSF after a 10-day treatment period with Posiphen® in subjects with amnestic MCI. The effects of this treatment on biomarkers will also be determined in CSF, whole blood, and plasma or serum as primary pharmacodynamic (PD) objectives.

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Alzheimer's Disease
  • Amnestic Mild Cognitive Impairment
Drug: Posiphen® tartrate capsules
Capsules administered (240 mg/day) for 10 days Capsules administered (160 mg/day) for 10 days
Other Name: Posiphen® Tartrate
Experimental: Posiphen® tartrate capsules
Intervention: Drug: Posiphen® tartrate capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Males or post-menopausal females aged 55 to 80 years, inclusive.
  2. Must have Mild Cognitive Impairment (MCI) (amnestic subtype) according to Petersen's criteria (2004).
  3. Mini Mental Status Examination (MMSE) score should be ≥24.
  4. Must score below a pre-determined cut-off score on the logical memory II delayed paragraph recall sub-test of the Wechsler Memory Scale Revised (WMS-R).
  5. Must have a Clinical Dementia Rating of 0.5 with a memory box score of 0.5 or 1.0.
  6. Modified Hachinski score of less than or equal to 4.
  7. Hamilton Depression rating scale (HAMD17) score of less than or equal to 12 with a score of 0 on items 1, 2, and 3 (depressed mood, feelings of guilt, and suicidal ideation).
  8. No evidence of current suicidal ideation or previous suicide attempt in past 2 years as evaluated in the Columbia Suicidality Checklist.
  9. MRI scans within 12 months prior to screening, or per screening MRI, without evidence of infection, infarction, or other focal lesions and without clinical symptoms suggestive of intervening neurological disease.
  10. No clinically significant abnormalities in the lumbar spine should be present on a lumbar X-ray that would contraindicate lumbar puncture.
  11. Adequate visual and hearing ability (physical ability to perform all the study assessments).
  12. Normal B12, folic acid, and thyroid function tests (thyroid stimulating hormone [TSH], free T4, and free T3).
  13. Do not require nursing home care.

Exclusion Criteria:

  1. Any significant neurologic disease other than amnestic MCI, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
  2. Major depression, schizophrenia or another major psychiatric disorder as described in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) within the past 2 years.
  3. Psychotic features, agitation, or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol.
  4. History of alcohol or substance abuse or dependence within the past 2 years.
  5. Subjects with any febrile illness within 1 week prior to the CSF collection.
  6. Subjects who have history of migraine headaches and any other type of headaches of at least moderate severity more than twice per month.
  7. Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol or pose potential risk to the subjects.
  8. Use of medications prohibited by the study.
  9. Any clinically significant laboratory abnormalities.
  10. Subjects with infection or inflammation of the skin or skin disease at or in proximity to the lumbar puncture site.
  11. History of lumbar spine surgery or chronic low back pain (CLBP).
Both
55 Years to 80 Years
No
Contact: Mark T Leibowitz, MD (210) 635-1500 mleibowitz@cedracorp.com
United States
 
NCT01072812
QR 12001
No
Maria Maccecchini, PhD, QR Pharma, Inc.
QR Pharma Inc.
Not Provided
Principal Investigator: Mark T Leibowitz, MD CEDRA
QR Pharma Inc.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP