Alzheimer DiseaseNCT01348061
Evaluating Cerebrospinal Fluid Biomarkers in Alzheimer's, Progressive Supranuclear Palsy Subjects, and Controls
An observational study of Alzheimer Disease and Progressive Supranuclear Palsy, run by KineMed at 3 sites in United States.
Trial summary
This is an experimental medicine study to evaluate the kinetics of cerebrospinal fluid (CSF) biomarkers in subjects with Alzheimer's disease (AD) or progressive supranuclear palsy (PSP) compared to healthy controls using a heavy water (2H2O) labeling method. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Progressive Supranuclear Palsy
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2011to Jul 2013
- Phase
- Observational
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: AD, PSP and EHV subjects will be recruited via Contract Research Organizations (CROs). Recruitment efforts will target the general population residing in communities in proximity to the CROs.
Who may be able to join
- All subjects
- Body Mass Index of 18-32.
- Subjects can have common non-neurological age-related disorders (hypertension, diabetes) and on stable medication for the last 3 months.
- Screening score of < 4 on the Modified Hachinski Ischemia Scale.
- Women not of childbearing potential and men.
- Women with negative pregnancy test prior to starting heavy water and not breastfeeding.
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- AD
- Diagnosis of probable AD.
- Mild to moderate disease severity according to mini-mental state examination score (MMSE) of 16-26.
- Documented cognitive decline began 6 months prior to screening.
- On stable doses of approved AD medications for 2 months prior to screening.
- Non-medicated AD subjects are free of AD medications for 2 months prior to screening.
- Mild to moderate white matter disease and up to 2 lacunar infarcts acceptable as determined by brain MRI at screening.
- Investigator determines subjects to be medically stable and physically able to complete the study.
- Minimum of 6 years of education and able to read, write and communicate effectively.
- Adequate hearing, vision, and language skills.
- Subjects and their caregivers must agree to the dosage regimens and procedures, report for scheduled visits, and communicate with study personnel.
- PSP
- Diagnosis of probable PSP.
- Brain MRI at screening excluding potential causes of parkinsonism, especially cerebrovascular and space occupying lesions.
- Mild-to-moderate stage of disease severity by a Golbe Staging System score of 1-3.
- Subjects and their caregivers must agree to the dosage regimens and procedures, report for scheduled visits, and communicate with study personnel.
- Currently on stable doses of PSP medications for 2 months prior to screening.
- Investigator determines subjects to be medically stable and able to complete the study.
- Minimum of 6 years of education and able to read, write and communicate effectively.
- Adequate hearing, vision, and language skills.
- EHV
- No clinically significant deviation from healthy for their age group.
- No subjective or objective memory loss.
- MMSE score of 28 to 30.
Who cannot join
- Diseased subjects with a medical condition (not AD or PSP) that could contribute to the subjects dementia or Parkinsonism.
- History of pallidotomy, thalamotomy, active DBS or fetal tissue transplant.
- Any significant acute or chronic illness.
- Major surgery within 4 weeks of Day 1.
- Blood/plasma donation to a blood bank or a clinical study (except a screening visit) within 4 weeks of Day 1.
- Blood transfusion within 4 weeks of Day 1.
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- Inability to be venipunctured.
- Inability to be lumbar punctured or contraindications to lumbar puncture or epidurals.
- > 10 cigarettes/day.
- Recent drug or alcohol abuse or positive urine screen for drugs of abuse.
- Subjects deemed inappropriate to undergo a MRI.
- Any medical, psychiatric or social reason as determined by the investigator.
- AD subjects with a history of CSF or amyloid imaging studies not consistent with Alzheimer's pathology.
- Healthy subjects with a history of CSF or amyloid imaging studies consistent with Alzheimer's pathology.
- Allergies to local anesthetics.
- Any significant drug allergy.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Memory Enhancement Centers of America Inc.
Eatontown, New Jersey, 07724
Parexel
Glendale, California, 91206
Worldwide Clinical Trials
San Antonio, Texas, 78217
About this study
Official title: Experimental Medicine Study to Evaluate the Kinetics of Cerebrospinal Fluid Biomarkers in Subjects With Alzheimer's Disease and Progressive Supranuclear Palsy Compared to Healthy Subjects Using a Heavy Water Labeling Method
This is an experimental medicine study to evaluate the kinetics of cerebrospinal fluid (CSF) biomarkers in subjects with Alzheimer's disease (AD) or progressive supranuclear palsy (PSP) compared to healthy controls using a heavy water (2H2O) labeling method. This study is exploring the time profile of appearance and disappearance of pulse deuterium-labeled cargo proteins in CSF of subjects with AD and/or PSP, which is different from healthy controls, due to deficits in fast axonal transport.
Read the detailed description
Primary Objective:
To compare the time profile of appearance and disappearance in CSF of pulse deuterium-labeled chromogranin B, sAPPα and β-Trace in AD and PSP subjects compared to healthy controls.
Secondary Objectives:
- To measure body water enrichment of deuterium in saliva and plasma (2H-enrichment (%))
- To explore the effect of age on the kinetics of deuterium labeling of CSF biomarkers
- To assess intra and inter subject variability of deuterium-labeling of chromogranin B, sAPPα and β-Trace
Subjects will undergo screening evaluations to determine eligibility prior to heavy water (2H20) administration. Eligible subjects will be admitted to the clinical facility on Day -1. On Day 1, subjects will ingest small doses of 2H20 during their inpatient stay. They will also drink 2H20 for 7 more days. Subjects will undergo two lumbar punctures (LPs) for CSF samples. Subjects will return to the study site approximately 7 days after the last LP (or early termination) for a follow-up assessment and discharge.
- Conditions
- Alzheimer Disease, Progressive Supranuclear Palsy
- Keywords
- Alzheimers Disease, Progressive Supranuclear Palsy, CSF, Cerebrospinal Fluid, Biomarker, Heavy Water, Cargo proteins
- Medical subject headings
- Alzheimer Disease, Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elderly Healthy Control (EHV) | No clinically significant deviation from healthy in medical history, physical examination, ECGs, MRI and clinical laboratory determinations for their respective age group. | |
| Progressive Supranuclear Palsy (PSP) | A diagnosis of possible or probable PSP according to clinical criteria of National Institute of Neurologic Diseases and Stroke - the Society for PSP plus a MRI at screening to exclude other potential causes of parkinsonism as well as a mild-to-moderate stage of disease severity according to a score of 1 to 3 in Golbe Staging System. | |
| Alzheimer's Disease (AD) | A diagnosis of probable AD Based on the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association and The Diagnostic and Statistical Manual of Mental Disorders as determined by a mini-mental state examination (MMSE) score of 16 to 26, inclusive. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker Measures
- Levels of deuterium-labeled chromogranin B, sAPPα and β-Trace in CSF
Measured: Up to 32 days
Secondary outcomes (1)
Biomarker Measures
- Body water enrichment of deuterium in saliva and plasma (2H-enrichment(%))
Measured: Up to 32 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- KineMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Salena Killion, KineMed
- Investigators
- Marc K Hellerstein, M.D., Ph.D., Study director, KineMed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348061
- Sponsor's protocol ID
- CN167001
- Status last verified
- Oct 2014
- First submitted
- 3 May 2011
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Medicine Study to Evaluate the Kinetics of Cerebrospinal Fluid Biomarkers in Subjects With Alzheimer's Disease and Progressive Supranuclear Palsy Compared to Healthy Subjects Using a Heavy Water Labeling Method
- ClinicalTrials.gov ID
- NCT01348061
- Acronym / sponsor ID
- CN167001
- Conditions
- Alzheimer Disease, Progressive Supranuclear Palsy
- Keywords
- Alzheimers Disease, Progressive Supranuclear Palsy, CSF, Cerebrospinal Fluid, Biomarker, Heavy Water, Cargo proteins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- KineMedIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jul 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 5 May 2011 (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 is an experimental medicine study to evaluate the kinetics of cerebrospinal fluid (CSF) biomarkers in subjects with Alzheimer's disease (AD) or progressive supranuclear palsy (PSP) compared to healthy controls using a heavy water (2H2O) labeling method. This study is exploring the time profile of appearance and disappearance of pulse deuterium-labeled cargo proteins in CSF of subjects with AD and/or PSP, which is different from healthy controls, due to deficits in fast axonal transport.
Detailed description
Primary Objective:
To compare the time profile of appearance and disappearance in CSF of pulse deuterium-labeled chromogranin B, sAPPα and β-Trace in AD and PSP subjects compared to healthy controls.
Secondary Objectives:
- To measure body water enrichment of deuterium in saliva and plasma (2H-enrichment (%))
- To explore the effect of age on the kinetics of deuterium labeling of CSF biomarkers
- To assess intra and inter subject variability of deuterium-labeling of chromogranin B, sAPPα and β-Trace
Subjects will undergo screening evaluations to determine eligibility prior to heavy water (2H20) administration. Eligible subjects will be admitted to the clinical facility on Day -1. On Day 1, subjects will ingest small doses of 2H20 during their inpatient stay. They will also drink 2H20 for 7 more days. Subjects will undergo two lumbar punctures (LPs) for CSF samples. Subjects will return to the study site approximately 7 days after the last LP (or early termination) for a follow-up assessment and discharge.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Elderly Healthy Control (EHV) | – | –No clinically significant deviation from healthy in medical history, physical examination, ECGs, MRI and clinical laboratory determinations for their respective age group. |
| Progressive Supranuclear Palsy (PSP) | – | –A diagnosis of possible or probable PSP according to clinical criteria of National Institute of Neurologic Diseases and Stroke - the Society for PSP plus a MRI at screening to exclude other potential causes of parkinsonism as well as a mild-to-moderate stage of disease severity according to a score of 1 to 3 in Golbe Staging System. |
| Alzheimer's Disease (AD) | – | –A diagnosis of probable AD Based on the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association and The Diagnostic and Statistical Manual of Mental Disorders as determined by a mini-mental state examination (MMSE) score of 16 to 26, inclusive. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- AD, PSP and EHV subjects will be recruited via Contract Research Organizations (CROs). Recruitment efforts will target the general population residing in communities in proximity to the CROs.
Key inclusion criteria (30 listed)
- All subjects
- Body Mass Index of 18-32.
- Subjects can have common non-neurological age-related disorders (hypertension, diabetes) and on stable medication for the last 3 months.
- Screening score of < 4 on the Modified Hachinski Ischemia Scale.
- Women not of childbearing potential and men.
Key exclusion criteria (16 listed)
- Diseased subjects with a medical condition (not AD or PSP) that could contribute to the subjects dementia or Parkinsonism.
- History of pallidotomy, thalamotomy, active DBS or fetal tissue transplant.
- Any significant acute or chronic illness.
- Major surgery within 4 weeks of Day 1.
- Blood/plasma donation to a blood bank or a clinical study (except a screening visit) within 4 weeks of Day 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biomarker Measures
Time frame: Up to 32 days
o Levels of deuterium-labeled chromogranin B, sAPPα and β-Trace in CSF
1 secondary outcome
Biomarker Measures
Time frame: Up to 32 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
- Related InfoLink provided by the sponsor.
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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.
Marc K Hellerstein, M.D., Ph.D. study director
KineMed
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Progressive Supranuclear Palsy, run by KineMed at 3 sites 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 30 inclusion and 16 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: finished, as of the sponsor's last update on 24 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Biomarker Measures (time frame: Up to 32 days). 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 24 Oct 2014.