Alzheimer Disease, Early OnsetPARMAAJJNCT03508024
Patients With Alzheimer's Disease or Related Youth Disease
An observational study of Alzheimer Disease, Early Onset and Lewy Body Disease, run by University Hospital, Lille at 1 site in France.
Trial summary
This study aims to determine factors related to diagnosis delay for patients with young onset dementia (first symptoms before 60 years old) who live in North of France. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease, Early Onset, Lewy Body Disease, Frontotemporal Lobar Degeneration
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jan 2018to 25 Apr 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a diagnosis of Alzheimer disease, Lewy Bodies Dementia or FrontoTemporal Lobar Degeneration and their caregivers
Who may be able to join
- As part of this study, patients will be considered:
- Residing in the departments of Nord (59) and Pas-de-Calais (62),
- whose diagnosis of Alzheimer's disease or related illness (DLFT, DCL) was made and announced,
- Whose diagnosis of illness was made after 2007
- whose first symptoms appeared before the age of 60 Patients included in the COMAJ cohort and those who completed the Pathways medical and social booklet will have to meet these criteria to be selected for this study.
- As part of the survey, caregivers of patients meeting the above criteria and the following two will be recruited:
- Having consulted or being followed by liberal neurologists or in hospital memory consultations (excluding CMRR-CNR-MAJ Lille) of the departments of Nord and Pas-de-Calais,
- Not monitored at the CMRR-CNR-MAJ Lille (ad hoc notice possible). The caregiver is defined as a family member or friend who helps regularly by doing the necessary tasks so that the sick person can keep as much autonomy as possible.
Who cannot join
- aged under 18
- no social coverage
- refusal to sign informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to determine factors related to diagnosis delay for patients with young onset dementia (first symptoms before 60 years old) who live in North of France.
- Medical subject headings
- Alzheimer Disease, Lewy Body Disease, Frontotemporal Lobar Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
the delay between the diagnosis and the first symptomsIdentification of factors related with diagnosis delay
To determine the factors associated with diagnostic delay in young patients (early symptoms before age 60) with Alzheimer's disease or related degenerative disease (Fronto-temporal Lobar Degeneration , Lewy Body Dementia )
Measured: 10 years
Secondary outcomes (4)
Comparison of patient profiles followed at the CMRR-CNR-MAJ Lille and those who are not.
The different profiles are defined according to composite measures of socio-demographic type
Measured: 10 years
Comparison of patients characteristics followed at the CMRR-CNR-MAJ Lille and those who are not.Impact of the diagnosis on YOD
The different characteristics are defined according to composite measures of socio-demographic type
Measured: 10 years
the percentage of patients who have had a lack of information about the disease and possible aids
Identification of medico-social issues taht have been encountered by YOD patients during the care
Measured: 10 years
the percentage of refusal or delay of treatment of certain medico-social aids by the competent authorities
Identification of medico-social issues taht have been encountered by YOD patients during the care
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start5 Jan 2018
- Primary completion25 Apr 2019
- Study completion25 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease, Early OnsetStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Retrospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Pasquier, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508024
- Sponsor's protocol ID
- NI_2016_39
- Other IDs
- 2017-A00486-47
- Acronym
- PARMAAJJ
- Status last verified
- Apr 2018
- First submitted
- 8 Nov 2017
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients With Alzheimer's Disease or Related Youth Disease
- ClinicalTrials.gov ID
- NCT03508024
- Acronym / sponsor ID
- PARMAAJJ / NI_2016_39
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 25 Apr 2019 (actual)
- Study completion
- 25 Apr 2019 (actual)
- First posted
- 25 Apr 2018 (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.
This study aims to determine factors related to diagnosis delay for patients with young onset dementia (first symptoms before 60 years old) who live in North of France.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a diagnosis of Alzheimer disease, Lewy Bodies Dementia or FrontoTemporal Lobar Degeneration and their caregivers
Key inclusion criteria (8 listed)
- Residing in the departments of Nord (59) and Pas-de-Calais (62),
- whose diagnosis of Alzheimer's disease or related illness (DLFT, DCL) was made and announced,
- Whose diagnosis of illness was made after 2007
- whose first symptoms appeared before the age of 60 Patients included in the COMAJ cohort and those who completed the Pathways medical and social booklet will have to meet these criteria to be selected for this study.
- As part of the survey, caregivers of patients meeting the above criteria and the following two will be recruited:
Key exclusion criteria (3 listed)
- aged under 18
- no social coverage
- refusal to sign informed consent form
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
the delay between the diagnosis and the first symptomsIdentification of factors related with diagnosis delay
Time frame: 10 years
To determine the factors associated with diagnostic delay in young patients (early symptoms before age 60) with Alzheimer's disease or related degenerative disease (Fronto-temporal Lobar Degeneration , Lewy Body Dementia )
4 secondary outcomes
Comparison of patient profiles followed at the CMRR-CNR-MAJ Lille and those who are not.
Time frame: 10 years
Comparison of patients characteristics followed at the CMRR-CNR-MAJ Lille and those who are not.Impact of the diagnosis on YOD
Time frame: 10 years
the percentage of patients who have had a lack of information about the disease and possible aids
Time frame: 10 years
the percentage of refusal or delay of treatment of certain medico-social aids by the competent authorities
Time frame: 10 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 25 Mar 2021.
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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.
Florence Pasquier, MD, PhD principal investigator
University Hospital, Lille
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 Disease, Early Onset and Lewy Body Disease, run by University Hospital, Lille 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 8 inclusion and 3 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 25 Mar 2021. 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?
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?
the delay between the diagnosis and the first symptomsIdentification of factors related with diagnosis delay (time frame: 10 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 25 Mar 2021.