Alzheimer DiseaseNCT03408041
Reported Time Between Onset and Diagnosis of Alzheimer's Disease: Correlation With Objective Parameters
An observational study of Alzheimer Disease, run by Murielle Surquin at 1 site in Belgium.
Trial summary
The early diagnosis of Alzheimer's disease is essential to enable patients to have access to the available treatments. However, there is a delay between the diagnosis and the onset of symptoms, which can range from 1 year to more than 5 years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Medical file data extraction
- How many people
- 129 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2016to 1 Oct 2017
- 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: Alzheimer Disease patients admitted in the 'Memory Clinic' of the CHU Brugmann Hospital between 01-01-2010 and 31-01-2013. Diagnose according to the Dubois criteria
Who may be able to join
- Alzheimer Disease patients admitted in the 'Memory Clinic' of the CHU Brugmann Hospital between 01-01-2010 and 31-01-2013. Diagnose according to the Dubois criteria
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The early diagnosis of Alzheimer's disease is essential to enable patients to have access to the available treatments. However, there is a delay between the diagnosis and the onset of symptoms, which can range from 1 year to more than 5 years. In clinical practice, the hippocampal volume, measured by the Scheltens index, is currently used as a marker of the progression of the disease.
The purpose of this study is to determine whether the patient's sex, age and ethnicity can influence the delay in the expression of cognitive troubles reported by the family at the first medical consultation, as well as to determine if there is a correlation between the delay reported by the family and the Scheltens index.
- Conditions
- Alzheimer Disease
- Being tested
- Medical file data extraction
- Keywords
- Alzheimer Disease, Objective parameters, Scheltens index
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical file data extractionOther
Medical file data extraction
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer Disease | Alzheimer Disease patients admitted in the 'Memory Clinic' of the CHU Brugmann Hospital between 01-01-2010 and 31-01-2013. Diagnose according to the Dubois criteria Receives: Other: Medical file data extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Age
Measured: Between 01-01-2010 and 31-01-2013
Sex
Sex
Measured: Between 01-01-2010 and 31-01-2013
Ethnic origin
Ethnic origin
Measured: Between 01-01-2010 and 31-01-2013
Symptoms-diagnose time interval
Interval of time between the apparition of the first symptoms, as reported by the family, and the diagnose.
Measured: Between 01-01-2010 and 31-01-2013
Scheltens scale
Evaluation of the hippocampal atrophy by means of magnetic resonance imaging. Scale from 0 (normal) to 4.
Measured: Between 01-01-2010 and 31-01-2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 May 2016
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murielle Surquin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Murielle Surquin, Brugmann University Hospital
- Investigators
- Florence Benoit, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408041
- Sponsor's protocol ID
- CHUB-parameters Alzheimer
- Status last verified
- Jan 2018
- First submitted
- 17 Jan 2018
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reported Time Between Onset and Diagnosis of Alzheimer's Disease: Correlation With Objective Parameters
- ClinicalTrials.gov ID
- NCT03408041
- Acronym / sponsor ID
- CHUB-parameters Alzheimer
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Disease, Objective parameters, Scheltens index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Murielle SurquinUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 23 Jan 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.
The early diagnosis of Alzheimer's disease is essential to enable patients to have access to the available treatments. However, there is a delay between the diagnosis and the onset of symptoms, which can range from 1 year to more than 5 years. In clinical practice, the hippocampal volume, measured by the Scheltens index, is currently used as a marker of the progression of the disease.
The purpose of this study is to determine whether the patient's sex, age and ethnicity can influence the delay in the expression of cognitive troubles reported by the family at the first medical consultation, as well as to determine if there is a correlation between the delay reported by the family and the Scheltens index.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alzheimer Disease | – | Other: Medical file data extractionAlzheimer Disease patients admitted in the 'Memory Clinic' of the CHU Brugmann Hospital between 01-01-2010 and 31-01-2013. Diagnose according to the Dubois criteria |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Alzheimer Disease patients admitted in the 'Memory Clinic' of the CHU Brugmann Hospital between 01-01-2010 and 31-01-2013. Diagnose according to the Dubois criteria
Key inclusion criteria (1 listed)
- Alzheimer Disease patients admitted in the 'Memory Clinic' of the CHU Brugmann Hospital between 01-01-2010 and 31-01-2013. Diagnose according to the Dubois criteria
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Medical file data extractionMedical file data extraction | Other | Alzheimer Disease |
Primary outcome
Age
Time frame: Between 01-01-2010 and 31-01-2013
Age
Sex
Time frame: Between 01-01-2010 and 31-01-2013
Sex
Ethnic origin
Time frame: Between 01-01-2010 and 31-01-2013
Ethnic origin
Symptoms-diagnose time interval
Time frame: Between 01-01-2010 and 31-01-2013
Interval of time between the apparition of the first symptoms, as reported by the family, and the diagnose.
Scheltens scale
Time frame: Between 01-01-2010 and 31-01-2013
Evaluation of the hippocampal atrophy by means of magnetic resonance imaging. Scale from 0 (normal) to 4.
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 23 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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 Benoit, MD principal investigator
CHU Brugmann
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, run by Murielle Surquin at 1 site in Belgium.
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 1 inclusion and 1 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 23 Jan 2018. 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 Belgium. 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?
Age (time frame: Between 01-01-2010 and 31-01-2013). The study lists 5 primary outcomes in all. 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 23 Jan 2018.