Alzheimer's DiseasePhase 1NCT01072812
Study of the Pharmacokinetics and Pharmacodynamics of POSIPHEN® in Subjects With Amnestic Mild Cognitive Impairment
A Phase 1 study testing Posiphen® tartrate capsules in people with Alzheimer's Disease and Amnestic Mild Cognitive Impairment, run by Annovis Bio Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Alzheimer's Disease, Amnestic Mild Cognitive Impairment
- What is being tested?
- Posiphen® tartrate capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jul 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or post-menopausal females aged 55 to 80 years, inclusive.
- Must have Mild Cognitive Impairment (MCI) (amnestic subtype) according to Petersen's criteria (2004).
- Mini Mental Status Examination (MMSE) score should be ≥24.
- 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).
- Must have a Clinical Dementia Rating of 0.5 with a memory box score of 0.5 or 1.0.
- Modified Hachinski score of less than or equal to 4.
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- 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).
- No evidence of current suicidal ideation or previous suicide attempt in past 2 years as evaluated in the Columbia Suicidality Checklist.
- 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.
- No clinically significant abnormalities in the lumbar spine should be present on a lumbar X-ray that would contraindicate lumbar puncture.
- Adequate visual and hearing ability (physical ability to perform all the study assessments).
- Normal B12, folic acid, and thyroid function tests (thyroid stimulating hormone [TSH], free T4, and free T3).
- Do not require nursing home care.
Who cannot join
- Any significant neurologic disease other than amnestic MCI, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
- 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.
- Psychotic features, agitation, or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol.
- History of alcohol or substance abuse or dependence within the past 2 years.
- Subjects with any febrile illness within 1 week prior to the CSF collection.
- Subjects who have history of migraine headaches and any other type of headaches of at least moderate severity more than twice per month.
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- Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol or pose potential risk to the subjects.
- Use of medications prohibited by the study.
- Any clinically significant laboratory abnormalities.
- Subjects with infection or inflammation of the skin or skin disease at or in proximity to the lumbar puncture site.
- History of lumbar spine surgery or chronic low back pain (CLBP).
Trial locations and contacts
1 site in 1 country.
United States1 site
CEDRA Clinical Research, LLC
San Antonio, Texas, 78217
About this study
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
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.
- Being tested
- Posiphen® tartrate capsules
- Keywords
- Alzheimer's, Amnestic Mild Cognitive Impairment, Pharmacokinetics, Pharmacodynamics, Biomarkers
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posiphen® tartrate capsulesDrug
Also called Posiphen® Tartrate
Capsules administered (240 mg/day) for 10 days Capsules administered (160 mg/day) for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Posiphen® tartrate capsules | Experimental | Not described Receives: Drug: Posiphen® tartrate capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
To determine the pharmacokinetics (PK) of Posiphen® and its metabolites in plasma and CSF after a 10-day treatment period with Posiphen®.
Measured: 10 days
Pharmacodynamics
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.
Measured: 10 days
Secondary outcomes (2)
Biomarkers
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.
Measured: 10 days
Safety
To determine the safety and tolerability of a 10-day treatment period with Posiphen®.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Business decision based on funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Annovis Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark T Leibowitz, MD, Principal investigator, CEDRA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072812
- Sponsor's protocol ID
- QR 12001
- Status last verified
- Apr 2015
- First submitted
- 19 Feb 2010
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01072812
- Acronym / sponsor ID
- QR 12001
- Keywords
- Alzheimer's, Amnestic Mild Cognitive Impairment, Pharmacokinetics, Pharmacodynamics, Biomarkers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision based on funding
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Annovis Bio Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 22 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Posiphen® tartrate capsules | Experimental | Drug: Posiphen® tartrate capsules |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Males or post-menopausal females aged 55 to 80 years, inclusive.
- Must have Mild Cognitive Impairment (MCI) (amnestic subtype) according to Petersen's criteria (2004).
- Mini Mental Status Examination (MMSE) score should be ≥24.
- 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).
- Must have a Clinical Dementia Rating of 0.5 with a memory box score of 0.5 or 1.0.
Key exclusion criteria (11 listed)
- Any significant neurologic disease other than amnestic MCI, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
- 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.
- Psychotic features, agitation, or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol.
- History of alcohol or substance abuse or dependence within the past 2 years.
- Subjects with any febrile illness within 1 week prior to the CSF collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posiphen® tartrate capsulesAlso: Posiphen® TartrateCapsules administered (240 mg/day) for 10 days Capsules administered (160 mg/day) for 10 days | Drug | Posiphen® tartrate capsules |
Primary outcome
Pharmacokinetics
Time frame: 10 days
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
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.
2 secondary outcomes
Biomarkers
Time frame: 10 days
Safety
Time frame: 10 days
Results and safety
The study was stopped early (reason given: Business decision based on funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark T Leibowitz, MD principal investigator
CEDRA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Posiphen® tartrate capsules in people with Alzheimer's Disease and Amnestic Mild Cognitive Impairment, run by Annovis Bio Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business decision based on funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2015.