Alzheimer's DiseaseNCT01730430
Cerebrospinal Fluid (CSF) Biomarkers Alzheimer's Disease (AD) and Non-AD Dementias
An observational study of Alzheimer's Disease and Dementias, run by Duke University at 1 site in United States.
Trial summary
To establish a cutoff value using a ratio of CSF tau to Aβ42 (tau/Aβ42) for distinguishing patients wth mild to moderate Alzheimer's disease (AD) from health elderly control subjects. The investigators hypothesize that a cutoff can be found that has at least 80% sensitivity and 60% specificity. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Dementias
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Dec 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 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Duke Memory Disorders Clinic
Who may be able to join
- Each subject must be ≥ 55 to ≤ 85 years of age.
- Each subject must be able to read at a 6th grade level, as determined by the investigator, and must have a history of academic achievement and/or employment sufficient to exclude mental retardation.
- Each subject must have results of clinical laboratory tests, a physical examination, vital signs within normal limits or clinically acceptable to the investigator within 28 days prior to enrollment.
- Each subject (or legal representative) must sign the informed consent form after the scope and nature of the investigation have been explained to them, and before screening assessments.
- Additional Inclusion Criteria for Normal Controls:
- Must have a global Clinical Dementia Rating (CDR) score of 0.
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- Must have a Mini-Mental State Examination (MMSE) score ≥ 28.
- Must have a Z-score ≥ -1.0 in each cognitive domain of memory (including delayed recall), language, executive function and attention, and visuoconstruction with neuropsychological tests of choice and adjustment for age, gender, and education level if indicated.
- Additional Inclusion Criteria for AD Subjects:
- Must meet the criteria for a diagnosis of probable AD based on both
- the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, and
- the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM IV TR) criteria for AD.
- Must have an MMSE score ≥ 15 and ≤ 26.
- Must have a clear history of cognitive and functional decline over at least one year that is either
- documented in medical records or
- documented by history from an informant who knows the subject well.
- Must have an MRI or CT scan that is consistent with a diagnosis of AD within 12 months prior to enrollment.
Who cannot join
- The subject has a Rosen modified Hachinski Ischemia Score > 4.
- The subject has a known history of stroke.
- The subject has evidence of a clinically relevant or unstable neurological or psychiatric disorder (for AD subjects - other than AD).
- The subject has a history of alcoholism or drug dependency/abuse within the last 5 years before enrollment.
- The subject has an ongoing uncontrolled, clinically significant medical condition such that, in the judgment of the investigator, a subject's participation in the trial would pose a significant medical risk to the subject.
- The subject has participated within the last two months in a clinical trial of a novel therapeutic agent (e.g. bapineuzumab) or has ever been in a clinical trial of an AD vaccine.
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- Pregnancy
- Additional Inclusion and Exclusion Criteria for Subject with non-AD dementias
- Standard clinical diagnostic criteria accepted by the field for non-AD dementias should be used by the Institution.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Health Center at Morreene Road
Durham, North Carolina, 27705
About this study
Official title: Investigation of Biomarkers of Disease State in Alzheimer's Disease and Non-AD Dementias
To establish a cutoff value using a ratio of CSF tau to Aβ42 (tau/Aβ42) for distinguishing patients wth mild to moderate Alzheimer's disease (AD) from health elderly control subjects. The investigators hypothesize that a cutoff can be found that has at least 80% sensitivity and 60% specificity.
Read the detailed description
This study will enroll 50 AD subjects, 50 normal controls and approximately 20 subjects with non-AD dementia. There will be 2 visits (up to 30 days apart), and a telephone follow-up visit.
This protocol does not include treatment of subjects. Lumbar puncture and phlebotomy are routine clinical tasks and are associated with a low level of risk. All adverse events will be documented and reviewed by the PI.
- Conditions
- Alzheimer's Disease, Dementias
- Keywords
- non-AD dementias, healthy elderly controls
- Medical subject headings
- Alzheimer Disease, Dementia
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 |
|---|---|---|
| Collection of CSF | 1. Those with Alzheimer's disease 2. Those with non-Alzheimer's disease dementia 3. Healthy elderly volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of CSF tau to Aβ42 (tau/Aβ42)
CSF will be collected in clinic and shipped frozen to Merck's Clinical Development Lab for testing. Any remaining samples will be kept up to 20 years.
Measured: CSF will be collected at Visit 1 (up to 30 days after the screening visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2013
- Study completionDec 2013
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.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- James Burke, MD, PhD, Principal investigator, Duke UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730430
- Sponsor's protocol ID
- Pro00033660
- Status last verified
- Apr 2014
- First submitted
- 17 Oct 2012
- Last updated
- 22 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Biomarkers of Disease State in Alzheimer's Disease and Non-AD Dementias
- ClinicalTrials.gov ID
- NCT01730430
- Acronym / sponsor ID
- Pro00033660
- Conditions
- Alzheimer's Disease, Dementias
- Keywords
- non-AD dementias, healthy elderly controls
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jul 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Nov 2012 (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.
To establish a cutoff value using a ratio of CSF tau to Aβ42 (tau/Aβ42) for distinguishing patients wth mild to moderate Alzheimer's disease (AD) from health elderly control subjects. The investigators hypothesize that a cutoff can be found that has at least 80% sensitivity and 60% specificity.
Detailed description
This study will enroll 50 AD subjects, 50 normal controls and approximately 20 subjects with non-AD dementia. There will be 2 visits (up to 30 days apart), and a telephone follow-up visit.
This protocol does not include treatment of subjects. Lumbar puncture and phlebotomy are routine clinical tasks and are associated with a low level of risk. All adverse events will be documented and reviewed by the PI.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Collection of CSF | – | –1. Those with Alzheimer's disease 2. Those with non-Alzheimer's disease dementia 3. Healthy elderly volunteers |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Duke Memory Disorders Clinic
Key inclusion criteria (17 listed)
- Each subject must be ≥ 55 to ≤ 85 years of age.
- Each subject must be able to read at a 6th grade level, as determined by the investigator, and must have a history of academic achievement and/or employment sufficient to exclude mental retardation.
- Each subject must have results of clinical laboratory tests, a physical examination, vital signs within normal limits or clinically acceptable to the investigator within 28 days prior to enrollment.
- Each subject (or legal representative) must sign the informed consent form after the scope and nature of the investigation have been explained to them, and before screening assessments.
- Must have a global Clinical Dementia Rating (CDR) score of 0.
Key exclusion criteria (9 listed)
- The subject has a Rosen modified Hachinski Ischemia Score > 4.
- The subject has a known history of stroke.
- The subject has evidence of a clinically relevant or unstable neurological or psychiatric disorder (for AD subjects - other than AD).
- The subject has a history of alcoholism or drug dependency/abuse within the last 5 years before enrollment.
- The subject has an ongoing uncontrolled, clinically significant medical condition such that, in the judgment of the investigator, a subject's participation in the trial would pose a significant medical risk to the subject.
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
Ratio of CSF tau to Aβ42 (tau/Aβ42)
Time frame: CSF will be collected at Visit 1 (up to 30 days after the screening visit)
CSF will be collected in clinic and shipped frozen to Merck's Clinical Development Lab for testing. Any remaining samples will be kept up to 20 years.
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 22 Apr 2014.
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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.
James Burke, MD, PhD principal investigator
Duke UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease and Dementias, run by Duke University 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 17 inclusion and 9 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 22 Apr 2014. 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.
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?
Ratio of CSF tau to Aβ42 (tau/Aβ42) (time frame: CSF will be collected at Visit 1 (up to 30 days after the screening visit)). 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 2014.