Down SyndromeNCT03901261
Cohort Study of Adult Patients With Down Syndrome at Risk of Developing Alzheimer's Disease (TriAL21)
A study testing Neuro-imaging, Lumbar puncture in people with Down Syndrome and Alzheimer Disease, run by Institut Jerome Lejeune at 1 site in France.
Trial summary
TriAL21 study is an interventional, open, one arm, prospective, national and single center study. A total of 200 patients with Down syndrome, aged 35 years and over, without diagnosis of Alzheimer's disease will be enrolled into the study. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Down Syndrome, Alzheimer Disease
- What is being tested?
- Neuro-imaging, Lumbar puncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2019to 31 Mar 2023
- Phase
- Interventional
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 35 years old and over ;
- Clinical diagnosis of Down syndrome ;
- Patient attending the geriatric outpatient clinic
- Patient without diagnosis of Alzheimer's disease;
- Patient covered by social welfare;
- Patient himself or legal guardian/representative willing and consenting to participate to the study by giving written informed consent;
- Patients must have a parent, or / and other reliable caregiver who agrees to accompany him/her to all visits, provide information about the patient as required by the protocol. The parent or caregiver must be a constant and reliable informant with sufficient contact with the patient to have detailed knowledge of the patient's adaptive functioning in order to be able to complete the assessments accurately.
Who cannot join
- Patient presenting a contraindication to MRI in particular carrier of metal implants such as pacemakers;
- Patient presenting a serious, severe or unstable pathology (left to the investigator's discretion) whose nature may interfere with the evaluation parameters;
- Patient without Alzheimer's disease diagnosis but with severe dementia;
- Participation in other clinical trials in the last 3 months prior to the study;
- Pregnant woman.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut Jérôme Lejeune
Paris, 75015
Anne-Sophie REBILLAT, MD, PhD, +33 1 56 58 63 00, annesophie.rebillat@institutlejeune.org
Anne-Sophie REBILLAT, MD
About this study
Official title: Cohort Study of Adult Patients With Down Syndrome at Risk of Developing Alzheimer's Disease
TriAL21 study is an interventional, open, one arm, prospective, national and single center study.
A total of 200 patients with Down syndrome, aged 35 years and over, without diagnosis of Alzheimer's disease will be enrolled into the study.
Participating centre is Institut Jérôme Lejeune; outpatient's clinic dedicated to treating patients with cognitive deficiencies of genetic origin including patients with Down syndrome.
Read the detailed description
The aim of the study is to describe and follow a cohort of patients with Down syndrome without diagnosis of Alzheimer's disease at inclusion, in order to identify factors influencing the age of onset of the disease.
The total study duration will be approximately 4 years.
- Inclusion period : 2 years
- Follow-up period per patient : 2 years
Patients will be then followed during 10 years for routine medical follow-up. In case of Alzheimer's disease onset during this period, all data regarding diagnosis of AD will be collected for the study. Data about dementia evolution and mortality in case of AD diagnosis during the study will also be collected during this follow-up period.
- Conditions
- Down Syndrome, Alzheimer Disease
- Being tested
- Neuro-imaging, Lumbar puncture
- Keywords
- Down Syndrome, Alzheimer Disease, Marker, Neuropsychological, Prodromal, Risk factors
- Medical subject headings
- Down Syndrome, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro-imaging, Lumbar punctureProcedure or surgery
Optional Lumbar Puncture will be performed at inclusion visit Optional Neuro-Imaging (MRI (Magnetic Resonance Imaging) will be performed within 3 months after inclusion visit
| Study group | Role | What they receive |
|---|---|---|
| Down syndrome patients | Experimental | Not described Receives: Procedure: Neuro-imaging, Lumbar puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age of onset of Alzheimer's disease
age (year)
Measured: 2 years
Gender that could influence the age of onset of the disease as determined by medical record review
Measured: 2 years
Level of intellectual diasability that could influence the age of onset of the disease as determined by medical record review
Measured: 2 years
Family history of Alzheimer's disease that could influence the age of onset of the disease as determined by medical record review
Measured: 2 years
Cardio-vascular risk factors that could influence the age of onset of the disease as determined by medical record review
Measured: 2 years
Down syndrome comorbidies that could influence the age of onset of the disease as determined by medical record review
Measured: 2 years
Genetic's factor other than APP that could influence the age of onset of the disease as determined by medical record review
Measured: 2 years
Head trauma that could influence the age of onset of the disease as determined by medical record review
Measured: 2 years
Age of menopause that could influence the age of onset of the disease as determined by medical record review
Measured: 2 years
Secondary outcomes (12)
Evaluation of neuropsychological evolution using Katz Index of Independence in Activities of Daily Living (Katz ADL) score
Questionnaire about Activities of Daily Living such as bathing, toileting, continence, dressing, transferring and feeding Scoring : Independence: 1 point - Partial dependence 0.5 point - Full dependence: 0 point
Measured: 2 years
Evaluation of neuropsychological evolution using Lawton-Brody Instrumental Activities of Daily Living scale ( IADL)
Questionnaire about strumental Activities of Daily Living such as ability to use telephone, responsibility for taking medication, travels independently on public transportation, ability to handle finances Scoring : 0 or 1
Measured: 2 years
Evaluation of neuropsychological evolution using Dementia Screening Questionnaire for Individuals with Intellectual Disabilities (DSQIID) score
Dementia Screening for Individuals with Intellectual Disabilities Questionnary is a autonomy and psychobeahavioral questionnaire to gather information from carers of people with Down's syndrome about the symptoms of dementia
Measured: 2 years
Evaluation of neuropsychological evolution using Cambridge Examination for Mental Disorders of Older People with Down's Syndrome and Others with Intellectual Disabilities score
Camdex-Ds. Based on an informant interview to aid the diagnosis of dementia in people with DS according to the DSM-IV et ICD criteria for dementia.
Measured: 2 years
Evaluation of neuropsychological evolution using Cambridge Cognition Examination score
It is part of the CAMDEX-DS. Section 2 involves the direct assessment of patient. It contains seven different subscales and has 46 items. it gives a total score of 108. Decline between assessment at Time 1 and assessment at time 2 in association with CAMDEX confirm or evoque the AD diagnosis.
Measured: 2 years
Evaluation of neuropsychological evolution using Cued Recall test score
It is a memory task. It consists in 12 items accompanied by a unique category cue, presented four a time in three trials. It generates two measures respectively for learning phase and delayed recall: a free recall score/12 and a total score/36 (FRS plus items recalled with cue) for the learnig phase. A free recall (FRS/12) and a total score (FRS plus items recalled with cue /12) for the delayed recall. Number of intrusions will be also recorded.
Measured: 2 years
Evaluation of neuropsychological evolution using Cancellation task
Measure of task accuracy (total number of correct responses, range score 0-16) and total time performance (in seconds) were included in the analyses.
Measured: 2 years
Evaluation of neuropsychological evolution using Leiter III assessment score
It is a nonverbal measure of intelligence \& cognitive abilities. It includes four subtests whose raw scores are converted to normalised scaled scores (mean [M] = 10, standard deviation [SD] = 3). It gives an IQ standard score (M = 100; SD = 15).
Measured: 2 years
Identification of prodromal Alzheimer's disease markers using brain imaging
Whole brain volumetry calculation, hippocampus volume calculation, white matter lesions volumetry calculation
Measured: 2 years
Identification of prodromal Alzheimer's disease markers using dosage (pg/mL) of biomarkers in cerebrospinal fluid
1-40 beta-amyloid, 1-42 beta-amyloid, tau, phosphorylated tau
Measured: 2 years
Number of adverse event and serious adverse events related to trial procedures
Adverse events graded 3-4-5 according to CTCAE v5.0
Measured: 2 years
Evaluation of survival assessed by vital status
Date and cause of death
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start26 Apr 2019
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional prospective monocentric, national open study with single arm
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Jerome Lejeune
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901261
- Sponsor's protocol ID
- TriAL21
- Status last verified
- Feb 2023
- First submitted
- 4 Feb 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sinai A, Mokrysz C, Bernal J, Bohnen I, Bonell S, Courtenay K, Dodd K, Gazizova D, Hassiotis A, Hillier R, McBrien J, McCarthy J, Mukherji K, Naeem A, Perez-Achiaga N, Rantell K, Sharma V, Thomas D, Walker Z, Whitham S, Strydom A. Predictors of Age of Diagnosis and Survival of Alzheimer's Disease in Down Syndrome. J Alzheimers Dis. 2018;61(2):717-728. doi: 10.3233/JAD-170624.
PubMed 29226868McCarron M, McCallion P, Reilly E, Dunne P, Carroll R, Mulryan N. A prospective 20-year longitudinal follow-up of dementia in persons with Down syndrome. J Intellect Disabil Res. 2017 Sep;61(9):843-852. doi: 10.1111/jir.12390. Epub 2017 Jun 29.
PubMed 28664561Mann DM. Alzheimer's disease and Down's syndrome. Histopathology. 1988 Aug;13(2):125-37. doi: 10.1111/j.1365-2559.1988.tb02018.x.
PubMed 2971602Coppus A, Evenhuis H, Verberne GJ, Visser F, van Gool P, Eikelenboom P, van Duijin C. Dementia and mortality in persons with Down's syndrome. J Intellect Disabil Res. 2006 Oct;50(Pt 10):768-77. doi: 10.1111/j.1365-2788.2006.00842.x.
PubMed 16961706Lautarescu BA, Holland AJ, Zaman SH. The Early Presentation of Dementia in People with Down Syndrome: a Systematic Review of Longitudinal Studies. Neuropsychol Rev. 2017 Mar;27(1):31-45. doi: 10.1007/s11065-017-9341-9. Epub 2017 Mar 13.
PubMed 28289920Neale N, Padilla C, Fonseca LM, Holland T, Zaman S. Neuroimaging and other modalities to assess Alzheimer's disease in Down syndrome. Neuroimage Clin. 2017 Nov 6;17:263-271. doi: 10.1016/j.nicl.2017.10.022. eCollection 2018.
PubMed 29159043Vemuri P, Jack CR Jr. Role of structural MRI in Alzheimer's disease. Alzheimers Res Ther. 2010 Aug 31;2(4):23. doi: 10.1186/alzrt47.
PubMed 20807454Lleo A, Cavedo E, Parnetti L, Vanderstichele H, Herukka SK, Andreasen N, Ghidoni R, Lewczuk P, Jeromin A, Winblad B, Tsolaki M, Mroczko B, Visser PJ, Santana I, Svenningsson P, Blennow K, Aarsland D, Molinuevo JL, Zetterberg H, Mollenhauer B. Cerebrospinal fluid biomarkers in trials for Alzheimer and Parkinson diseases. Nat Rev Neurol. 2015 Jan;11(1):41-55. doi: 10.1038/nrneurol.2014.232. Epub 2014 Dec 16.
PubMed 25511894Hulstaert F, Blennow K, Ivanoiu A, Schoonderwaldt HC, Riemenschneider M, De Deyn PP, Bancher C, Cras P, Wiltfang J, Mehta PD, Iqbal K, Pottel H, Vanmechelen E, Vanderstichele H. Improved discrimination of AD patients using beta-amyloid(1-42) and tau levels in CSF. Neurology. 1999 May 12;52(8):1555-62. doi: 10.1212/wnl.52.8.1555.
PubMed 10331678KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.
PubMed 14044222Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
PubMed 5349366Deb S, Hare M, Prior L, Bhaumik S. Dementia screening questionnaire for individuals with intellectual disabilities. Br J Psychiatry. 2007 May;190:440-4. doi: 10.1192/bjp.bp.106.024984.
PubMed 17470960Ball SL, Holland AJ, Huppert FA, Treppner P, Watson P, Hon J. The modified CAMDEX informant interview is a valid and reliable tool for use in the diagnosis of dementia in adults with Down's syndrome. J Intellect Disabil Res. 2004 Sep;48(Pt 6):611-20. doi: 10.1111/j.1365-2788.2004.00630.x.
PubMed 15312062Kim J, Basak JM, Holtzman DM. The role of apolipoprotein E in Alzheimer's disease. Neuron. 2009 Aug 13;63(3):287-303. doi: 10.1016/j.neuron.2009.06.026.
PubMed 19679070Carmona-Iragui M, Santos T, Videla S, Fernandez S, Benejam B, Videla L, Alcolea D, Blennow K, Blesa R, Lleo A, Fortea J. Feasibility of Lumbar Puncture in the Study of Cerebrospinal Fluid Biomarkers for Alzheimer's Disease in Subjects with Down Syndrome. J Alzheimers Dis. 2017;55(4):1489-1496. doi: 10.3233/JAD-160827.
PubMed 27858714
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Adult Patients With Down Syndrome at Risk of Developing Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03901261
- Acronym / sponsor ID
- TriAL21
- Conditions
- Down Syndrome, Alzheimer Disease
- Keywords
- Down Syndrome, Alzheimer Disease, Marker, Neuropsychological, Prodromal, Risk factors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institut Jerome LejeuneUniversity, hospital or other
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 3 Apr 2019 (actual)
- 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.
TriAL21 study is an interventional, open, one arm, prospective, national and single center study.
A total of 200 patients with Down syndrome, aged 35 years and over, without diagnosis of Alzheimer's disease will be enrolled into the study.
Participating centre is Institut Jérôme Lejeune; outpatient's clinic dedicated to treating patients with cognitive deficiencies of genetic origin including patients with Down syndrome.
Detailed description
The aim of the study is to describe and follow a cohort of patients with Down syndrome without diagnosis of Alzheimer's disease at inclusion, in order to identify factors influencing the age of onset of the disease.
The total study duration will be approximately 4 years.
- Inclusion period : 2 years
- Follow-up period per patient : 2 years
Patients will be then followed during 10 years for routine medical follow-up. In case of Alzheimer's disease onset during this period, all data regarding diagnosis of AD will be collected for the study. Data about dementia evolution and mortality in case of AD diagnosis during the study will also be collected during this follow-up period.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional prospective monocentric, national open study with single arm
| Arm | Type | Receives |
|---|---|---|
| Down syndrome patients | Experimental | Procedure: Neuro-imaging, Lumbar puncture |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female 35 years old and over ;
- Clinical diagnosis of Down syndrome ;
- Patient attending the geriatric outpatient clinic
- Patient without diagnosis of Alzheimer's disease;
- Patient covered by social welfare;
Key exclusion criteria (5 listed)
- Patient presenting a contraindication to MRI in particular carrier of metal implants such as pacemakers;
- Patient presenting a serious, severe or unstable pathology (left to the investigator's discretion) whose nature may interfere with the evaluation parameters;
- Patient without Alzheimer's disease diagnosis but with severe dementia;
- Participation in other clinical trials in the last 3 months prior to the study;
- Pregnant woman.
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 |
|---|---|---|
| Neuro-imaging, Lumbar punctureOptional Lumbar Puncture will be performed at inclusion visit Optional Neuro-Imaging (MRI (Magnetic Resonance Imaging) will be performed within 3 months after inclusion visit | Procedure or surgery | Down syndrome patients |
Primary outcome
Age of onset of Alzheimer's disease
Time frame: 2 years
age (year)
Gender that could influence the age of onset of the disease as determined by medical record review
Time frame: 2 years
Level of intellectual diasability that could influence the age of onset of the disease as determined by medical record review
Time frame: 2 years
Family history of Alzheimer's disease that could influence the age of onset of the disease as determined by medical record review
Time frame: 2 years
Cardio-vascular risk factors that could influence the age of onset of the disease as determined by medical record review
Time frame: 2 years
Down syndrome comorbidies that could influence the age of onset of the disease as determined by medical record review
Time frame: 2 years
Genetic's factor other than APP that could influence the age of onset of the disease as determined by medical record review
Time frame: 2 years
Head trauma that could influence the age of onset of the disease as determined by medical record review
Time frame: 2 years
Age of menopause that could influence the age of onset of the disease as determined by medical record review
Time frame: 2 years
12 secondary outcomes
Evaluation of neuropsychological evolution using Katz Index of Independence in Activities of Daily Living (Katz ADL) score
Time frame: 2 years
Evaluation of neuropsychological evolution using Lawton-Brody Instrumental Activities of Daily Living scale ( IADL)
Time frame: 2 years
Evaluation of neuropsychological evolution using Dementia Screening Questionnaire for Individuals with Intellectual Disabilities (DSQIID) score
Time frame: 2 years
Evaluation of neuropsychological evolution using Cambridge Examination for Mental Disorders of Older People with Down's Syndrome and Others with Intellectual Disabilities score
Time frame: 2 years
Evaluation of neuropsychological evolution using Cambridge Cognition Examination score
Time frame: 2 years
Evaluation of neuropsychological evolution using Cued Recall test score
Time frame: 2 years
Evaluation of neuropsychological evolution using Cancellation task
Time frame: 2 years
Evaluation of neuropsychological evolution using Leiter III assessment score
Time frame: 2 years
Identification of prodromal Alzheimer's disease markers using brain imaging
Time frame: 2 years
Identification of prodromal Alzheimer's disease markers using dosage (pg/mL) of biomarkers in cerebrospinal fluid
Time frame: 2 years
Number of adverse event and serious adverse events related to trial procedures
Time frame: 2 years
Evaluation of survival assessed by vital status
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 29226868Sinai A, Mokrysz C, Bernal J, Bohnen I, Bonell S, Courtenay K, Dodd K, Gazizova D, Hassiotis A, Hillier R, McBrien J, McCarthy J, Mukherji K, Naeem A, Perez-Achiaga N, Rantell K, Sharma V, Thomas D, Walker Z, Whitham S, Strydom A. Predictors of Age of Diagnosis and Survival of Alzheimer's Disease in Down Syndrome. J Alzheimers Dis. 2018;61(2):717-728. doi: 10.3233/JAD-170624.
- Background: PubMed 28664561McCarron M, McCallion P, Reilly E, Dunne P, Carroll R, Mulryan N. A prospective 20-year longitudinal follow-up of dementia in persons with Down syndrome. J Intellect Disabil Res. 2017 Sep;61(9):843-852. doi: 10.1111/jir.12390. Epub 2017 Jun 29.
- Background: PubMed 2971602Mann DM. Alzheimer's disease and Down's syndrome. Histopathology. 1988 Aug;13(2):125-37. doi: 10.1111/j.1365-2559.1988.tb02018.x.
- Background: PubMed 16961706Coppus A, Evenhuis H, Verberne GJ, Visser F, van Gool P, Eikelenboom P, van Duijin C. Dementia and mortality in persons with Down's syndrome. J Intellect Disabil Res. 2006 Oct;50(Pt 10):768-77. doi: 10.1111/j.1365-2788.2006.00842.x.
- Background: PubMed 28289920Lautarescu BA, Holland AJ, Zaman SH. The Early Presentation of Dementia in People with Down Syndrome: a Systematic Review of Longitudinal Studies. Neuropsychol Rev. 2017 Mar;27(1):31-45. doi: 10.1007/s11065-017-9341-9. Epub 2017 Mar 13.
- Background: PubMed 29159043Neale N, Padilla C, Fonseca LM, Holland T, Zaman S. Neuroimaging and other modalities to assess Alzheimer's disease in Down syndrome. Neuroimage Clin. 2017 Nov 6;17:263-271. doi: 10.1016/j.nicl.2017.10.022. eCollection 2018.
- Background: PubMed 20807454Vemuri P, Jack CR Jr. Role of structural MRI in Alzheimer's disease. Alzheimers Res Ther. 2010 Aug 31;2(4):23. doi: 10.1186/alzrt47.
- Background: PubMed 25511894Lleo A, Cavedo E, Parnetti L, Vanderstichele H, Herukka SK, Andreasen N, Ghidoni R, Lewczuk P, Jeromin A, Winblad B, Tsolaki M, Mroczko B, Visser PJ, Santana I, Svenningsson P, Blennow K, Aarsland D, Molinuevo JL, Zetterberg H, Mollenhauer B. Cerebrospinal fluid biomarkers in trials for Alzheimer and Parkinson diseases. Nat Rev Neurol. 2015 Jan;11(1):41-55. doi: 10.1038/nrneurol.2014.232. Epub 2014 Dec 16.
- Background: PubMed 10331678Hulstaert F, Blennow K, Ivanoiu A, Schoonderwaldt HC, Riemenschneider M, De Deyn PP, Bancher C, Cras P, Wiltfang J, Mehta PD, Iqbal K, Pottel H, Vanmechelen E, Vanderstichele H. Improved discrimination of AD patients using beta-amyloid(1-42) and tau levels in CSF. Neurology. 1999 May 12;52(8):1555-62. doi: 10.1212/wnl.52.8.1555.
- Background: PubMed 14044222KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.
- Background: PubMed 5349366Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
- Background: PubMed 17470960Deb S, Hare M, Prior L, Bhaumik S. Dementia screening questionnaire for individuals with intellectual disabilities. Br J Psychiatry. 2007 May;190:440-4. doi: 10.1192/bjp.bp.106.024984.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuro-imaging, Lumbar puncture in people with Down Syndrome and Alzheimer Disease, run by Institut Jerome Lejeune at 1 site in France.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Sophie REBILLAT, MD, PhD (+33 1 56 58 63 00, annesophie.rebillat@institutlejeune.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age of onset of Alzheimer's disease (time frame: 2 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03901261, which also lists 15 linked publications.
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 8 Feb 2023.