Down SyndromeNCT01303133
Natural History of Amyloid Deposition in Adults With Down Syndrome
An observational study of Down Syndrome, run by University of Pittsburgh at 2 sites in United States.
Trial summary
The primary objective of this study is to assess the presence of amyloid in non-demented/functionally stable adults with DS as a function of age, dividing the sample into amyloid-positive and amyloid-negative groups. We will also obtain baseline cognitive measures across a range of areas that are often affected by AD. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- How many people
- 81 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2009to 31 Mar 2018
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Non-Demented Adults with Down Syndrome, ages 30 and above
Who may be able to join
- Participant IQ at least 47 (based upon Stanford-Binet V Abbrev. Test Battery)
- Participant at least 30 years of age
- DSDS score indicating participant is asymptomatic for AD
- Reliable caregiver who is capable of providing correct information about the participant's clinical symptoms and history
- Agreement of caregiver and clinician that participant is able to cooperate with the protocol tasks
- Participant has provided assent (or consent) and/or parent/caregiver has provided informed consent
Who cannot join
- Participant is non-verbal or has extremely limited language skills
- Score within the "symptomatic" range on the DSDS
- Any significant disease or unstable medical condition that could affect neuropsychological testing
- Any problems with vision or hearing that could affect neuropsychological testing
- Participants in whom MRI is contraindicated
- Claustrophobia or prior failed experiences of completing MRI scans or blood draws
- Participant is pregnant or breast feeding
- History or other evidence of severe illness or other condition that would make the participant, in the opinion of the investigator, unsuitable for the study?
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Waisman Center at the University of Wisconsin - Madison
Madison, Wisconsin, 53705
University of Pittsburgh and University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15203
About this study
The primary objective of this study is to assess the presence of amyloid in non-demented/functionally stable adults with DS as a function of age, dividing the sample into amyloid-positive and amyloid-negative groups. We will also obtain baseline cognitive measures across a range of areas that are often affected by AD.
Read the detailed description
Specific Aim 1: To assess and compare amyloid deposition (with PiB PET) in non-demented/functionally stable adults with DS across three age cohorts (30-39, 40-49, and >50 years of age).
Primary Hypothesis 1: At initial assessment, there will be a significantly higher prevalence of amyloid-positive (PiB+) subjects in each succeeding age cohort.
In addition, we will test the following secondary hypothesis:
Secondary Aim 1: To compare the presence or absence of the apolipoprotein-E4 allele to the retention of PiB in various brain areas of the DS subjects.
Secondary Hypothesis 1: At baseline, subjects who carry at least one Apolipoprotein-E4 (ApoE4) allele will show a higher prevalence of being PiB+.
- Conditions
- Down Syndrome
- Keywords
- beta amyloid, Down Syndrome, Alzheimer's Disease
- Medical subject headings
- Down Syndrome, Plaque, Amyloid, Alzheimer Disease
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 |
|---|---|---|
| Adults with Down Syndrome ages 30+ (PiB-/-) | We will be recruiting healthy adults with Down syndrome ages 30 and over. Participants cannot have a diagnosis of dementia. | |
| Adults with Down Syndrome ages 30+ (PiB-/+) | Not described | |
| Adults with Down Syndrome ages 30+ (PiB+/+) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amyloid deposition
Obtained via PiB PET scan
Measured: every 36 months for 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startAug 2009
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Benjamin L Handen, PhD, BCBA-D, University of Pittsburgh
- Investigators
- Benjamin Handen, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303133
- Sponsor's protocol ID
- PRO09080266
- Other IDs
- 2R01AG031110-03A1
- Status last verified
- Jan 2019
- First submitted
- 22 Feb 2011
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Amyloid Deposition in Adults With Down Syndrome
- ClinicalTrials.gov ID
- NCT01303133
- Acronym / sponsor ID
- PRO09080266
- Conditions
- Down Syndrome
- Keywords
- beta amyloid, Down Syndrome, Alzheimer's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Aug 2009
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 24 Feb 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.
The primary objective of this study is to assess the presence of amyloid in non-demented/functionally stable adults with DS as a function of age, dividing the sample into amyloid-positive and amyloid-negative groups. We will also obtain baseline cognitive measures across a range of areas that are often affected by AD.
Detailed description
Specific Aim 1: To assess and compare amyloid deposition (with PiB PET) in non-demented/functionally stable adults with DS across three age cohorts (30-39, 40-49, and >50 years of age).
Primary Hypothesis 1: At initial assessment, there will be a significantly higher prevalence of amyloid-positive (PiB+) subjects in each succeeding age cohort.
In addition, we will test the following secondary hypothesis:
Secondary Aim 1: To compare the presence or absence of the apolipoprotein-E4 allele to the retention of PiB in various brain areas of the DS subjects.
Secondary Hypothesis 1: At baseline, subjects who carry at least one Apolipoprotein-E4 (ApoE4) allele will show a higher prevalence of being PiB+.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adults with Down Syndrome ages 30+ (PiB-/-) | – | –We will be recruiting healthy adults with Down syndrome ages 30 and over. Participants cannot have a diagnosis of dementia. |
| Adults with Down Syndrome ages 30+ (PiB-/+) | – | – |
| Adults with Down Syndrome ages 30+ (PiB+/+) | – | – |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Non-Demented Adults with Down Syndrome, ages 30 and above
Key inclusion criteria (6 listed)
- Participant IQ at least 47 (based upon Stanford-Binet V Abbrev. Test Battery)
- Participant at least 30 years of age
- DSDS score indicating participant is asymptomatic for AD
- Reliable caregiver who is capable of providing correct information about the participant's clinical symptoms and history
- Agreement of caregiver and clinician that participant is able to cooperate with the protocol tasks
Key exclusion criteria (8 listed)
- Participant is non-verbal or has extremely limited language skills
- Score within the "symptomatic" range on the DSDS
- Any significant disease or unstable medical condition that could affect neuropsychological testing
- Any problems with vision or hearing that could affect neuropsychological testing
- Participants in whom MRI is contraindicated
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
Amyloid deposition
Time frame: every 36 months for 9 years
Obtained via PiB PET scan
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 9 Jan 2019.
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Down Syndrome
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.
Benjamin Handen, PhD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome, run by University of Pittsburgh at 2 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 6 inclusion and 8 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 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Amyloid deposition (time frame: every 36 months for 9 years). 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 9 Jan 2019.