Frail ElderlyCOGFRAILNCT03129269
Cognitive Function and Prevalence of Amyloid Marker in Frail Older Adults
A study testing MRI and PET scan in people with Frail Elderly, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The current study seeks to examine the prevalence of amyloid pathology, among patients referred to the Toulouse Geriatric Frailty Clinic presenting objective memory impairment. We also aim to fully characterize the clinical progression of frail cognitively impaired patients presenting AD (Alzheimer Disease) pathology… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frail Elderly
- What is being tested?
- MRI and PET scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2017to 16 Jun 2024
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Female and male individuals referred to the Toulouse Frailty Clinic with an objective memory impairment (CDR=0.5 or CDR=1)
- Age ≥ 70 years
- At least 1 Fried-criterion
- Informed consent signed by the patient
- Having an informant accompanying or available by phone
- Individuals affiliated to a healthcare scheme.
Show all 10Show fewer
- - Willing to be informed in case of a new pathology discovered through medical examination
- Extension study (Cog-Frail Plus):
- COGFRAIL study participants still included in the study and completing their last visit (M 24)
- Having a family member or legal representant to sign the consent form if MMSE score <20 at the last visit (M24)
Who cannot join
- Individuals presenting severe visual or auditory difficulties which may interfere with the completion of neuropsychological and functional assessments.
- Presence of any pathology or severe clinical or psychological condition that, according to the investigator, might interfere with study results or may expose the participants to additional risks.
- Individuals who are robust according to the Fried criteria (0 criteria)
- Individuals who are dependent (Activities of Daily Living (ADL) <4)
- Individuals who have a major deterioration in global cognitive function (Mini Mental State Examination (MMSE) <20)
- Subjects deprived of their liberty by administrative or judicial decision, or under guardianship or admitted to a healthcare or social institution (subjects in non-assisted living facilities could be recruited);
Show all 12Show fewer
- Claustrophobia
- Trauma or surgery which may have left ferromagnetic material in the body, including pacemakers
- History of neurosurgery or aneurism
- Extension study (Cog-Frail Plus):
- Presence of any severe pathology that, according to the investigator, might interfere with study results or may expose the participants to additional risks.
- Subjects deprived of their liberty by administrative or judicial decision, or under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
The current study seeks to examine the prevalence of amyloid pathology, among patients referred to the Toulouse Geriatric Frailty Clinic presenting objective memory impairment. We also aim to fully characterize the clinical progression of frail cognitively impaired patients presenting AD (Alzheimer Disease) pathology vs those who also present a cognitive impairment but do not have AD pathology.
Read the detailed description
The COGFRAIL study is a monocentric study integrating the longitudinal follow-up of 345 individuals referred to the Toulouse Frailty Clinic during 2 years. The procedure consists in neuroimaging to diagnose the presence of amyloid plaques in the brains and permit earlier detection of Alzheimer's disease.
- Visits will be scheduled at baseline, 1 and 2 years for a full neuropsychological, functional and physical evaluation.
- At 6 and 18 months patients will be seen in consultation by a Geriatrician and research assistant for a medical check.
- PET-Scan will be scheduled in the 2 months following inclusion for amyloid measurements. The MRI will be proposed, depending on the clinical relevance
- A blood sample for biobank will be taken at visit 2 and at the end of the study
Extension study (CogFrail-Plus):
The extension study will integrate an additional 2 years follow-up of the
COGFRAIL study participants, following the initial 2 years period of the study:
- 2 Visits will be scheduled at 36 and 48 months for a full neuropsychological, functional and physical evaluation
- At 30 and 42 months patients will be seen in consultation by a Geriatrician and research assistant for a medical check
- A blood sample will be taken at 36 and 48 months.
- Conditions
- Frail Elderly
- Being tested
- MRI and PET scan
- Keywords
- Cognitive decline, frailty, mild cognitive impairment, Positron Emission Tomography, PET, Alzheimer disease, amyloid load, Magnetic resonance imaging, MRI
- Medical subject headings
- Cognitive Dysfunction, Frailty, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI and PET scanProcedure or surgery
Neuroimaging with MRI and PET scan Amyloid tracer : For PET-scans, 4 MBq/kg of [18F]AV-45 will be injected into each subject in an intravenous bolus.
| Study group | Role | What they receive |
|---|---|---|
| neuroimaging amyloid diagnosis by MRI and PET scan | Experimental | There is only one arm. The procedure consists in neuroimaging to diagnose the presence of amyloid plaques in the brains and permit earlier detection of Alzheimer's disease. MRI and PET Scan.
* Visits at baseline, 1 and 2 years for a full neuropsychological, functional and physical evaluation.
* At 6 and 18 months in consultation by a Geriatrician and research assistant for a medical check.
* one PET-Scan in the 2 months following inclusion for amyloid measurements and one MRI, depending on the clinical relevance
* A blood sample for biobank at visit 2 and at visit 5.
Extension study (CogFrail-Plus): additional 2 years follow-up of the COGFRAIL study participants, following the initial 2 years period of the study:
* 2 Visits at at 36 and 48 months for a full neuropsychological, functional and physical evaluation
* At 30 and 42 months in consultation by a Geriatrician and research assistant for a medical check
* A blood sample at 36 and 48 months. Receives: Procedure: MRI and PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amyloid physiological parameter
Amyloid pathology as corroborated with amyloid Positron Emission Tomography (PET) or lumbar punction
Measured: 2 months after inclusion
Secondary outcomes (4)
Change in cognitive function with Clinical Dementia Rating Scale (CDR)
Comparison between 2 timeframe to observe change in cognitive function between T12, T24 months
Measured: 12 and 24 months
Changes in functional capacities with scales IADL
Changes in functional capacities, body composition, frailty phenotype, dietary intake and nutritional status with Instrumental Activities of Daily Living (IADL), Activities of Daily Living (ADL), Short Physical Performance Battery (SPPB).
All measures analysed together, parameters are linked and must be evaluated all together to get the main information.
Measured: 12 and 24 months
Changes in functional capacities with scales ADL
Changes in functional capacities, body composition, frailty phenotype, dietary intake and nutritional status with Instrumental Activities of Daily Living (IADL), Activities of Daily Living (ADL), Short Physical Performance Battery (SPPB).
All measures analysed together, parameters are linked and must be evaluated all together to get the main information.
Measured: 12 and 24 months
Changes in functional capacities with scales SPPB
Changes in functional capacities, body composition, frailty phenotype, dietary intake and nutritional status with Instrumental Activities of Daily Living (IADL), Activities of Daily Living (ADL), Short Physical Performance Battery (SPPB).
All measures analysed together, parameters are linked and must be evaluated all together to get the main information.
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start2 Jan 2017
- Primary completion16 Jun 2024
- Study completion16 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Frail ElderlyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- MSDAVENIR
- Responsible party
- Sponsor
- Investigators
- Bruno VELLAS, MD, Ph D, Pr, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129269
- Sponsor's protocol ID
- RC31/16/8753
- Acronym
- COGFRAIL
- Status last verified
- Apr 2026
- First submitted
- 2 Mar 2017
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Robertson DA, Savva GM, Kenny RA. Frailty and cognitive impairment--a review of the evidence and causal mechanisms. Ageing Res Rev. 2013 Sep;12(4):840-51. doi: 10.1016/j.arr.2013.06.004. Epub 2013 Jul 4.
PubMed 23831959Panza F, Solfrizzi V, Barulli MR, Santamato A, Seripa D, Pilotto A, Logroscino G. Cognitive Frailty: A Systematic Review of Epidemiological and Neurobiological Evidence of an Age-Related Clinical Condition. Rejuvenation Res. 2015 Oct;18(5):389-412. doi: 10.1089/rej.2014.1637. Epub 2015 Aug 20.
PubMed 25808052Kojima G, Taniguchi Y, Iliffe S, Walters K. Frailty as a Predictor of Alzheimer Disease, Vascular Dementia, and All Dementia Among Community-Dwelling Older People: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2016 Oct 1;17(10):881-8. doi: 10.1016/j.jamda.2016.05.013. Epub 2016 Jun 17.
PubMed 27324809Buchman AS, Schneider JA, Leurgans S, Bennett DA. Physical frailty in older persons is associated with Alzheimer disease pathology. Neurology. 2008 Aug 12;71(7):499-504. doi: 10.1212/01.wnl.0000324864.81179.6a.
PubMed 18695161Buchman AS, Yu L, Wilson RS, Schneider JA, Bennett DA. Association of brain pathology with the progression of frailty in older adults. Neurology. 2013 May 28;80(22):2055-61. doi: 10.1212/WNL.0b013e318294b462. Epub 2013 May 1.
PubMed 23635961Tavassoli N, Guyonnet S, Abellan Van Kan G, Sourdet S, Krams T, Soto ME, Subra J, Chicoulaa B, Ghisolfi A, Balardy L, Cestac P, Rolland Y, Andrieu S, Nourhashemi F, Oustric S, Cesari M, Vellas B; Geriatric Frailty Clinic (G.F.C) for Assessment of Frailty and Prevention of Disability Team. Description of 1,108 older patients referred by their physician to the "Geriatric Frailty Clinic (G.F.C) for Assessment of Frailty and Prevention of Disability" at the gerontopole. J Nutr Health Aging. 2014 May;18(5):457-64. doi: 10.1007/s12603-014-0462-z.
PubMed 24886728Grande de Franca NA, Diaz G, Lengele L, Soriano G, Caspar-Bauguil S, Saint-Aubert L, Payoux P, Rouch L, Vellas B, de Souto Barreto P, Sourdet S. Associations Between Blood Nutritional Biomarkers and Cerebral Amyloid-beta: Insights From the COGFRAIL Cohort Study. J Gerontol A Biol Sci Med Sci. 2024 Jan 1;79(1):glad248. doi: 10.1093/gerona/glad248.
PubMed 37879623Sourdet S, Soriano G, Delrieu J, Steinmeyer Z, Guyonnet S, Saint-Aubert L, Payoux P, Ousset PJ, Ghisolfi A, Chicoulaa B, Dardenne S, Gemar T, Baziard M, Guerville F, Andrieu S, Vellas B. Cognitive Function and Amyloid Marker in Frail Older Adults: The COGFRAIL Cohort Study. J Frailty Aging. 2021;10(2):160-167. doi: 10.14283/jfa.2020.57.
PubMed 33575706Lengele L, Sourdet S, Soriano G, Rolland Y, Soler V, de Souto Barreto P. Cross-sectional associations of dietary intake with hearing and vision capacities and potential mediation effect of inflammation in older adults: the COGFRAIL study. Aging Clin Exp Res. 2023 Jun;35(6):1325-1337. doi: 10.1007/s40520-023-02418-7. Epub 2023 Apr 29.
PubMed 37119508Bellelli F, Delrieu J, van Kan GA, Peluso A, Soriano G, Vellas B, Angioni D, Sourdet S. Are pre-frail and frail amyloid positive individuals eligible to Lecanemab? A cross-sectional analysis from the Cogfrail real-world cohort. Alzheimers Res Ther. 2026 Feb 4;18(1):56. doi: 10.1186/s13195-026-01966-0.
PubMed 41634843Sawicki A, Gonzalez-Bautista E, Peluso A, Abellan van Kan G, Sourdet S, Soto M. Mild behavioral impairment is longitudinally associated with frailty in very old adults with MCI: insights from COGFRAIL. Aging Clin Exp Res. 2026 Feb 3;38(1):64. doi: 10.1007/s40520-025-03309-9.
PubMed 41632436
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Function and Prevalence of Amyloid Marker in Frail Older Adults
- ClinicalTrials.gov ID
- NCT03129269
- Acronym / sponsor ID
- COGFRAIL / RC31/16/8753
- Conditions
- Frail Elderly
- Keywords
- Cognitive decline, frailty, mild cognitive impairment, Positron Emission Tomography, PET, Alzheimer disease, amyloid load, Magnetic resonance imaging, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- MSDAVENIR
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 16 Jun 2024 (actual)
- Study completion
- 16 Jun 2024 (actual)
- First posted
- 26 Apr 2017 (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 current study seeks to examine the prevalence of amyloid pathology, among patients referred to the Toulouse Geriatric Frailty Clinic presenting objective memory impairment. We also aim to fully characterize the clinical progression of frail cognitively impaired patients presenting AD (Alzheimer Disease) pathology vs those who also present a cognitive impairment but do not have AD pathology.
Detailed description
The COGFRAIL study is a monocentric study integrating the longitudinal follow-up of 345 individuals referred to the Toulouse Frailty Clinic during 2 years. The procedure consists in neuroimaging to diagnose the presence of amyloid plaques in the brains and permit earlier detection of Alzheimer's disease.
- Visits will be scheduled at baseline, 1 and 2 years for a full neuropsychological, functional and physical evaluation.
- At 6 and 18 months patients will be seen in consultation by a Geriatrician and research assistant for a medical check.
- PET-Scan will be scheduled in the 2 months following inclusion for amyloid measurements. The MRI will be proposed, depending on the clinical relevance
- A blood sample for biobank will be taken at visit 2 and at the end of the study
Extension study (CogFrail-Plus):
The extension study will integrate an additional 2 years follow-up of the
COGFRAIL study participants, following the initial 2 years period of the study:
- 2 Visits will be scheduled at 36 and 48 months for a full neuropsychological, functional and physical evaluation
- At 30 and 42 months patients will be seen in consultation by a Geriatrician and research assistant for a medical check
- A blood sample will be taken at 36 and 48 months.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neuroimaging amyloid diagnosis by MRI and PET scan | Experimental | Procedure: MRI and PET scanThere is only one arm. The procedure consists in neuroimaging to diagnose the presence of amyloid plaques in the brains and permit earlier detection of Alzheimer's disease. MRI and PET Scan. * Visits at baseline, 1 and 2 years for a full neuropsychological, functional and physical evaluation. * At 6 and 18 months in consultation by a Geriatrician and research assistant for a medical check. * one PET-Scan in the 2 months following inclusion for amyloid measurements and one MRI, depending on the clinical relevance * A blood sample for biobank at visit 2 and at visit 5. Extension study (CogFrail-Plus): additional 2 years follow-up of the COGFRAIL study participants, following the initial 2 years period of the study: * 2 Visits at at 36 and 48 months for a full neuropsychological, functional and physical evaluation * At 30 and 42 months in consultation by a Geriatrician and research assistant for a medical check * A blood sample at 36 and 48 months. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Female and male individuals referred to the Toulouse Frailty Clinic with an objective memory impairment (CDR=0.5 or CDR=1)
- Age ≥ 70 years
- At least 1 Fried-criterion
- Informed consent signed by the patient
- Having an informant accompanying or available by phone
Key exclusion criteria (12 listed)
- Individuals presenting severe visual or auditory difficulties which may interfere with the completion of neuropsychological and functional assessments.
- Presence of any pathology or severe clinical or psychological condition that, according to the investigator, might interfere with study results or may expose the participants to additional risks.
- Individuals who are robust according to the Fried criteria (0 criteria)
- Individuals who are dependent (Activities of Daily Living (ADL) <4)
- Individuals who have a major deterioration in global cognitive function (Mini Mental State Examination (MMSE) <20)
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 |
|---|---|---|
| MRI and PET scanNeuroimaging with MRI and PET scan Amyloid tracer : For PET-scans, 4 MBq/kg of [18F]AV-45 will be injected into each subject in an intravenous bolus. | Procedure or surgery | neuroimaging amyloid diagnosis by MRI and PET scan |
Primary outcome
Amyloid physiological parameter
Time frame: 2 months after inclusion
Amyloid pathology as corroborated with amyloid Positron Emission Tomography (PET) or lumbar punction
4 secondary outcomes
Change in cognitive function with Clinical Dementia Rating Scale (CDR)
Time frame: 12 and 24 months
Changes in functional capacities with scales IADL
Time frame: 12 and 24 months
Changes in functional capacities with scales ADL
Time frame: 12 and 24 months
Changes in functional capacities with scales SPPB
Time frame: 12 and 24 months
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 4 May 2026.
- Background: PubMed 23831959Robertson DA, Savva GM, Kenny RA. Frailty and cognitive impairment--a review of the evidence and causal mechanisms. Ageing Res Rev. 2013 Sep;12(4):840-51. doi: 10.1016/j.arr.2013.06.004. Epub 2013 Jul 4.
- Background: PubMed 25808052Panza F, Solfrizzi V, Barulli MR, Santamato A, Seripa D, Pilotto A, Logroscino G. Cognitive Frailty: A Systematic Review of Epidemiological and Neurobiological Evidence of an Age-Related Clinical Condition. Rejuvenation Res. 2015 Oct;18(5):389-412. doi: 10.1089/rej.2014.1637. Epub 2015 Aug 20.
- Background: PubMed 27324809Kojima G, Taniguchi Y, Iliffe S, Walters K. Frailty as a Predictor of Alzheimer Disease, Vascular Dementia, and All Dementia Among Community-Dwelling Older People: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2016 Oct 1;17(10):881-8. doi: 10.1016/j.jamda.2016.05.013. Epub 2016 Jun 17.
- Background: PubMed 18695161Buchman AS, Schneider JA, Leurgans S, Bennett DA. Physical frailty in older persons is associated with Alzheimer disease pathology. Neurology. 2008 Aug 12;71(7):499-504. doi: 10.1212/01.wnl.0000324864.81179.6a.
- Background: PubMed 23635961Buchman AS, Yu L, Wilson RS, Schneider JA, Bennett DA. Association of brain pathology with the progression of frailty in older adults. Neurology. 2013 May 28;80(22):2055-61. doi: 10.1212/WNL.0b013e318294b462. Epub 2013 May 1.
- Background: PubMed 24886728Tavassoli N, Guyonnet S, Abellan Van Kan G, Sourdet S, Krams T, Soto ME, Subra J, Chicoulaa B, Ghisolfi A, Balardy L, Cestac P, Rolland Y, Andrieu S, Nourhashemi F, Oustric S, Cesari M, Vellas B; Geriatric Frailty Clinic (G.F.C) for Assessment of Frailty and Prevention of Disability Team. Description of 1,108 older patients referred by their physician to the "Geriatric Frailty Clinic (G.F.C) for Assessment of Frailty and Prevention of Disability" at the gerontopole. J Nutr Health Aging. 2014 May;18(5):457-64. doi: 10.1007/s12603-014-0462-z.
- Results publication: PubMed 37879623Grande de Franca NA, Diaz G, Lengele L, Soriano G, Caspar-Bauguil S, Saint-Aubert L, Payoux P, Rouch L, Vellas B, de Souto Barreto P, Sourdet S. Associations Between Blood Nutritional Biomarkers and Cerebral Amyloid-beta: Insights From the COGFRAIL Cohort Study. J Gerontol A Biol Sci Med Sci. 2024 Jan 1;79(1):glad248. doi: 10.1093/gerona/glad248.
- Results publication: PubMed 33575706Sourdet S, Soriano G, Delrieu J, Steinmeyer Z, Guyonnet S, Saint-Aubert L, Payoux P, Ousset PJ, Ghisolfi A, Chicoulaa B, Dardenne S, Gemar T, Baziard M, Guerville F, Andrieu S, Vellas B. Cognitive Function and Amyloid Marker in Frail Older Adults: The COGFRAIL Cohort Study. J Frailty Aging. 2021;10(2):160-167. doi: 10.14283/jfa.2020.57.
- Results publication: PubMed 37119508Lengele L, Sourdet S, Soriano G, Rolland Y, Soler V, de Souto Barreto P. Cross-sectional associations of dietary intake with hearing and vision capacities and potential mediation effect of inflammation in older adults: the COGFRAIL study. Aging Clin Exp Res. 2023 Jun;35(6):1325-1337. doi: 10.1007/s40520-023-02418-7. Epub 2023 Apr 29.
- Derived from this study: PubMed 41634843Bellelli F, Delrieu J, van Kan GA, Peluso A, Soriano G, Vellas B, Angioni D, Sourdet S. Are pre-frail and frail amyloid positive individuals eligible to Lecanemab? A cross-sectional analysis from the Cogfrail real-world cohort. Alzheimers Res Ther. 2026 Feb 4;18(1):56. doi: 10.1186/s13195-026-01966-0.
- Derived from this study: PubMed 41632436Sawicki A, Gonzalez-Bautista E, Peluso A, Abellan van Kan G, Sourdet S, Soto M. Mild behavioral impairment is longitudinally associated with frailty in very old adults with MCI: insights from COGFRAIL. Aging Clin Exp Res. 2026 Feb 3;38(1):64. doi: 10.1007/s40520-025-03309-9.
- Individual participant dataSharing planned: No
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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.
Bruno VELLAS, MD, Ph D, Pr principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and PET scan in people with Frail Elderly, run by University Hospital, Toulouse 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 10 inclusion and 12 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 4 May 2026. 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?
Amyloid physiological parameter (time frame: 2 months after inclusion). 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 NCT03129269, which also lists 11 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 4 May 2026.