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
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Amnestic Mild Cognitive Impairment
Drug: Posiphen® tartrate capsules
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by QR Pharma Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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®.


Estimated Enrollment: 30
Study Start Date: February 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072812

Contacts
Contact: Mark T Leibowitz, MD (210) 635-1500 mleibowitz@cedracorp.com

Locations
United States, Texas
CEDRA Clinical Research, LLC Recruiting
San Antonio, Texas, United States, 78217
Contact: Mark T Leibowitz, MD    210-635-1500    mleibowitz@cedracorp.com   
Principal Investigator: Mark T Leibowitz, MD         
Sponsors and Collaborators
QR Pharma Inc.
Investigators
Principal Investigator: Mark T Leibowitz, MD CEDRA
  More Information

No publications provided

Responsible Party: Maria Maccecchini, PhD, QR Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01072812     History of Changes
Other Study ID Numbers: QR 12001
Study First Received: February 19, 2010
Last Updated: June 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by QR Pharma Inc.:
Alzheimer's
Amnestic Mild Cognitive Impairment
Pharmacokinetics
Pharmacodynamics
Biomarkers

Additional relevant MeSH terms:
Mild Cognitive Impairment
Alzheimer Disease
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2014