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
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San Antonio |
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Texas |
| Zip Code: |
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78217 |
| Conditions: |
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Alzheimer's Disease - Amnestic Mild Cognitive Impairment |
| Purpose: |
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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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| Study Summary: |
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| Criteria: |
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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).
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| NCT ID: |
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NCT01072812 |
| Primary Contact: |
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Principal Investigator
Mark T Leibowitz, MD
CEDRA
Mark T Leibowitz, MD
Phone: (210) 635-1500
Email: mleibowitz@cedracorp.com
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| Backup Contact: |
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N/A |
| Location Contact: |
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San Antonio, Texas 78217
United States
Mark T Leibowitz, MD
Phone: 210-635-1500
Email: mleibowitz@cedracorp.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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