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Study of the Pharmacokinetics and Pharmacodynamics of POSIPHEN® in Subjects With Amnestic Mild Cognitive Impairment | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

NCT01072812•Annovis Bio Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

55 - 80 years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

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.
+1 more criteria

Locations (1)

CEDRA Clinical Research, LLC

San Antonio, Texas, United States

Key Dates

Start Date

February 1, 2010

Primary Completion Date

July 1, 2010

Completion Date

July 1, 2010

Last Updated

April 22, 2015

Enrollment

ACTUAL participants

Conditions

Alzheimer's DiseaseAmnestic Mild Cognitive Impairment

Interventions

Posiphen® tartrate capsules

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 22, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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