Alzheimer DiseaseALFA3pilotNCT05516667
Cohort of Patients with Alzheimer's Disease and Their Families.
An observational study of Alzheimer Disease, run by University Hospital, Toulouse at 4 sites in France.
Trial summary
This is the pilot phase of a longitudinal observational cohort study. The study includes family clusters comprised of a patient with Alzheimer's disease, an informal caregiver and at least one first-degree relative of the patient. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- How many people
- 1,000 participants
- Where
- 4 sitesFrance
- Study dates
- 6 Apr 2023to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 3 types of participants : patients with AD, caregivers assisting such patients on daily activities, and close relatives as defined above
Who may be able to join
None listed.
Who cannot join
- AD patients:
- Other brain disorders
- Autosomal dominant form of AD
- Under legal protection measure (guardianship, curators, safeguard of justice…)
- Institutionalized
- Life expectancy <2 years
Show all 14Show fewer
- Caregivers:
- Under legal protection measure (guardianship, curators, safeguard of justice…)
- Diagnosed with a major neurocognitive disorder
- First-degree relatives:
- Related to a patient with an autosomal dominant form of dementia
- Carrier of an autosomal dominant dementia mutation
- Under legal protection measure (guardianship, curators, safeguard of justice…)
- Diagnosed with a major neurocognitive disorder
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nicola Coley, PhD contact
France4 sites, 4 recruiting
- Recruiting
Hôpitaux Universitaires de Marseille Timone
France, Marseille, 13005
CECCALDI Mathieu, 0491385928, mathieu.ceccaldi@ap-hp.fr
- Recruiting
CMRR Centre de Montpellier
Montpellier
Karim BENNYS, 0467337232, k-benny@chu-montpellier.fr
- Recruiting
CMRR Centre de Rouen
Rouen
DAVID WALLON, 0608972959, david.wallon@chu-rouen.fr
- Recruiting
CMRR - CRC Centre de Toulouse
Toulouse
Pierre-Jean OUSSET, 0561777070, ousset.pj@chu-toulouse.fr
About this study
Official title: Pilot Phase of a Prospective Cohort of Patients with Alzheimer's Disease and Their Families
This is the pilot phase of a longitudinal observational cohort study. The study includes family clusters comprised of a patient with Alzheimer's disease, an informal caregiver and at least one first-degree relative of the patient. The family clusters will be followed-up in expert memory centers and online in order to study risk and prognostic factors (including blood-based biomarkers) in the first-degree relatives and patients, respectively, as well as caregiver health, difficulties and needs. This pilot study is performed to assess the feasibility of conducting a larger-scale study.
Read the detailed description
Alzheimer's disease (AD) is a progressive neurodegenerative disease and the primary cause of dementia. It brings about a huge burden for patients, families and society as a whole. There is currently no curative treatment available, but the existence of a long preclinical period, during which biomarker changes are observed, and the identification of modifiable risk factors suggest that AD may be preventable. Data is currently lacking, however, on the trajectories and predictive value of blood-based biomarkers (which are more acceptable and less costly to measure than traditional imaging and Cerebrospinal fluid biomarkers biomarkers). Furthermore, although there has been much research into modifiable AD risk factors, they have often not been studied simultaneously in the same cohort, and there has been relatively little research into newly identified risk factors, such as hearing impairment. First-degree relatives of AD patients would seem an ideal population to study such factors, since they are at increased risk of dementia and cognitive decline, and may be more motivated to participate in dementia research studies than other individuals. Finally, although caregiver burden and quality of life have been previously studied, further data is required on their longitudinal trajectories, particularly taking into account the disease course of the patients they care for. Caregivers' needs and coping and caregiving strategies also need to be better understood. In the pilot phase of the ALFA3 study, 150 familial clusters (each comprised of a patient with Alzheimer's disease, a family caregiver and at least one first-degree relative of the patient) will be recruited and followed-up for 2 years in expert memory centers and via online questionnaires. This pilot phase will be used to study the feasibility of conducting a larger-scale study.
- Conditions
- Alzheimer Disease
- Keywords
- dementia, caregivers, risk factors, prognosis, first-degree relatives
- Medical subject headings
- Alzheimer Disease, Dementia
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
rate of actual inclusion on anticipated inclusion 9 months and 18-months after the first inclusion. Expressed in percentage
Measured: 18-months after the first inclusion
Retention rate
rate of remaining participants on actual inclusions 24 months after the first subject was included. Expressed in percentage
Measured: 24 months after the first inclusion
Secondary outcomes (1)
Cognitive function
Evolution of the Mini Mental State Examination score : from Baseline to the end of follow-up.
The scores can vary from 0 to 30; 0 being the lowest cognitive function and 30 representing "non pathological" functioning.
Measured: 60 months after Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start6 Apr 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
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.
- More trials run by University Hospital, ToulouseThe 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- France Alzheimer
- Responsible party
- Sponsor
- Investigators
- Sandrine Andrieu, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516667
- Sponsor's protocol ID
- RC31/21/0575
- Acronym
- ALFA3pilot
- Status last verified
- Dec 2024
- First submitted
- 23 Aug 2022
- Last updated
- 19 Dec 2024
- 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 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Phase of a Prospective Cohort of Patients with Alzheimer's Disease and Their Families
- ClinicalTrials.gov ID
- NCT05516667
- Acronym / sponsor ID
- ALFA3pilot / RC31/21/0575
- Conditions
- Alzheimer Disease
- Keywords
- dementia, caregivers, risk factors, prognosis, first-degree relatives
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- France Alzheimer
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 25 Aug 2022 (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 is the pilot phase of a longitudinal observational cohort study. The study includes family clusters comprised of a patient with Alzheimer's disease, an informal caregiver and at least one first-degree relative of the patient. The family clusters will be followed-up in expert memory centers and online in order to study risk and prognostic factors (including blood-based biomarkers) in the first-degree relatives and patients, respectively, as well as caregiver health, difficulties and needs. This pilot study is performed to assess the feasibility of conducting a larger-scale study.
Detailed description
Alzheimer's disease (AD) is a progressive neurodegenerative disease and the primary cause of dementia. It brings about a huge burden for patients, families and society as a whole. There is currently no curative treatment available, but the existence of a long preclinical period, during which biomarker changes are observed, and the identification of modifiable risk factors suggest that AD may be preventable. Data is currently lacking, however, on the trajectories and predictive value of blood-based biomarkers (which are more acceptable and less costly to measure than traditional imaging and Cerebrospinal fluid biomarkers biomarkers). Furthermore, although there has been much research into modifiable AD risk factors, they have often not been studied simultaneously in the same cohort, and there has been relatively little research into newly identified risk factors, such as hearing impairment. First-degree relatives of AD patients would seem an ideal population to study such factors, since they are at increased risk of dementia and cognitive decline, and may be more motivated to participate in dementia research studies than other individuals. Finally, although caregiver burden and quality of life have been previously studied, further data is required on their longitudinal trajectories, particularly taking into account the disease course of the patients they care for. Caregivers' needs and coping and caregiving strategies also need to be better understood. In the pilot phase of the ALFA3 study, 150 familial clusters (each comprised of a patient with Alzheimer's disease, a family caregiver and at least one first-degree relative of the patient) will be recruited and followed-up for 2 years in expert memory centers and via online questionnaires. This pilot phase will be used to study the feasibility of conducting a larger-scale study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 3 types of participants : patients with AD, caregivers assisting such patients on daily activities, and close relatives as defined above
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- Other brain disorders
- Autosomal dominant form of AD
- Under legal protection measure (guardianship, curators, safeguard of justice…)
- Institutionalized
- Life expectancy <2 years
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
Recruitment rate
Time frame: 18-months after the first inclusion
rate of actual inclusion on anticipated inclusion 9 months and 18-months after the first inclusion. Expressed in percentage
Retention rate
Time frame: 24 months after the first inclusion
rate of remaining participants on actual inclusions 24 months after the first subject was included. Expressed in percentage
1 secondary outcome
Cognitive function
Time frame: 60 months after Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
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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.
Nicola Coley, PhD contact
Sandrine Andrieu, MD principal investigator
University Hospital, Toulouse
4 sites 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 University Hospital, Toulouse at 4 sites 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 0 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandrine Andrieu, MD PhD (05 61 14 59 63, sandrine.andrieu@univ-tlse3.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 18-months after the first inclusion). The study lists 2 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 19 Dec 2024.