Clinical Trial Details

NCT ID: NCT01072812
Date Last Changed: June 11, 2011


Research Study Summary

A clinical trial to evaluate treatments using Posiphen® tartrate capsules for patients with Alzheimer's Disease or Amnestic Mild Cognitive Impairment

Research Study 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


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.

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Recruitment Details

Both Male and Female
55 to 80 Years
Overall Status
Lead Sponsor
QR Pharma Inc.
19 Months
Facility Type


Both Male and Female ages 55 Years to 80 Years

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).

Site Locations (1)

Country State City Zip Facility and Contact
United States Texas San Antonio 78217 CEDRA Clinical Research, LLC
Mark T Leibowitz, MD

Mark T Leibowitz, MD
Principal Investigator


Mark T Leibowitz, MD
(210) 635-1500

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