Alzheimer DiseaseNCT05433363
Renji Alzheimer's Disease Neuroimaging Cohort Study
An observational study of Alzheimer Disease, run by RenJi Hospital at 1 site in China.
Trial summary
This study focuses on the population of Alzheimer disease (AD). Based on Aβ(A)-Tau(T)-Vascular(V)-Neurodegeneration(N) (ATV(N))-AD evaluation system of NIA-AA Association, it can accurately diagnose and predict early AD. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 14 Feb 2022to Feb 2023
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care population; primary care clinic; memory clinic
Who may be able to join
- 1) Age: 50-75 years old; 2) complaints of memory decline; 3) Education≥ 6 years; 4) Be able to cooperate with the whole neuropsychological examinations; 5) No PET-MRI or brain MRI contraindications; 6) Sign informed consent.
- normal control: 1) Age: 50-75 years old; 2) No complaints of memory decline; 3) Mini-Mental State Examination (MMSE) ≥ 26 points; 4) Education years ≥ 6 years; 5) Be able to cooperate with a full set of neuropsychological examinations; 6) No PET-MRI or brain MRI contraindications; 7) Sign informed consent.
Who cannot join
- 1) Serious mental illness; 2) Severe depression: Hamilton Depression Scale (HAMD-17) scores ≥ 24; 3) Serious heart, liver, kidney and other important organ diseases; 4) PET-MRI or brain MRI contraindications
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, 200127
About this study
This study focuses on the population of Alzheimer disease (AD). Based on Aβ(A)-Tau(T)-Vascular(V)-Neurodegeneration(N) (ATV(N))-AD evaluation system of NIA-AA Association, it can accurately diagnose and predict early AD. Positron emission tomography (PET) - magnetic resonance (MR) was used to perform Aβ、Tau molecular imaging, representing A and T in the system respectively; The quantitative detection of glucose metabolism in the brain by fluorodeoxyglucose PET (FDG-PET) can reflect the degree of neuronal damage (N); In addition, PET-MR can be used to synchronously evaluate the patients' vascular comorbidity (SVD load score) (V). Through the preliminary construction of this system, to clarify the central deposition pattern of Aβ、tau protein and the characteristics of FDG metabolism; To clarify the correlation between PET-MR imaging indexes and the progression of early cognitive impairment in AD, and to clarify the role of degeneration and vascular factors in the occurrence and development of AD; To provide a preliminary basis for the subsequent establishment of a molecular imaging model for the prognosis of early AD.
Read the detailed description
Alzheimer disease (AD) is the most common cognitive impairment disease, which is mainly manifested in memory loss, language function and logical thinking disorder, and ultimately leads to the loss of independent living ability of patients. China has become the country with the largest number of AD patients in the world. At present, it has reached more than 8 million. The AD incidence rate of the elderly over 65 years old is 4%-6%, which seriously affects the health of the elderly. At present, the medicines used in clinical practice are only symptomatic treatment, and have no effect on reversing the course of disease. Studies have shown that AD has a preclinical period of more than 10 years. In this period, patients have specific pathological changes in the brain, but there are no obvious clinical symptoms. However, if the intervention is started after significant cognitive impairment, irreversible changes have taken place in the brain, and the intervention effect is limited. In recent years, many drug clinical studies on ad specific pathophysiological processes have not achieved positive results, which may be one of the important reasons why the study failed to include subjects in the early stage of the disease.
In this context, in 2011, the National Institute of Aging and the Alzheimer's Association (NIA-AA) developed diagnostic criteria for preclinical AD, mild cognitive impairment (MCI) due to AD, and dementia due to AD, which are based on AD specific biomarkers, transform the prenatal diagnosis of AD from clinical symptomatology architecture to central biomarker architecture (gold standard). The latter refers to β Amyloid protein（Aβ), Phosphorylated tau (p-tau) and secondary neurodegenerative injury (neurodegeneration), the so-called AT(N) architecture, in which "A" and "T" are AD specific lesions, and "A" is the earliest landmark change. Through in vivo detection of AD specific central markers to identify AD as early as possible and carry out targeted intervention, it is expected to provide the possibility for AD reversal. On the other hand, it is well known that AD tends to occur in the elderly, and there are often small vessel disease (SVD) coexisting in varying degrees. Both can work together to lead to AD progression. How to define the interaction between the two in the occurrence and progression of disease is also the focus of clinical research on AD. In this context, the 2018 NIA-AA standard update pointed out that the AT(N) architecture can be extended according to the AD comorbidity. For example, if AD is complicated with cerebrovascular disease, AT (N) can be correspondingly extended to ATV (N). The international clinical research based on AT(N) is very limited, while the research on ATV (N) is blank at present.
At present, PET-CT or PET-MR can be used to perform aβ and Tau molecular imaging and FDG-PET can reflect the damage degree of neurons through the quantitative detection of brain glucose metabolism, and realize the early accurate individual diagnosis of AD based on AT(N) architecture. PET-MR can also realize the simultaneous evaluation of patients' vascular comorbidity. For example, the SVD load score of MRI images is often used in clinical evaluation. Therefore, PET-MR research is carried out on patients with AD-MCI, It can realize the early accurate identification and comprehensive evaluation of AD based on AT(V) N architecture, and help to explore the contribution of degenerative factors and vascular load to the occurrence and development of cognition. It is a hot spot in clinical research in the field of AD at present, and it is in urgent need of breakthrough. At present, the research on the central biomarkers of early clinical AD is very limited, especially the longitudinal study which is combination of Aβ、 Tau and FDG multimodal PET images.
- Conditions
- Alzheimer Disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| normal control | normal, cognitive test normal, PET(-) | |
| cognitive disorder due to AD | PET Aβ（+），MCI-AD and AD dementia | |
| cognitive disorder NOT due to AD | PET Aβ（-），MCI or dementia not due to AD |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish AD accurate evaluation model
Using PET-MR to establish AD accurate evaluation model based on ATV (N) evaluation system
Measured: from 2022-02 to 2022-08
to analyze the correlation of PET-MR imaging indicators in AD progression
PET-MR imaging indicators were used to analyze the correlation between the progress of cognitive impairment in AD and to prepare for the follow-up study
Measured: From 2022-08 to 2023-02
To clarify the role of degeneration and vascular factors in the development of cognition
To clarify the role of degeneration and vascular factors in the development of cognition
Measured: From 2022-08 to 2023-02
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start14 Feb 2022
- Primary completionDec 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qun Xu, professor, Principal investigator, Renji Hospital, Shanghai Jiaotong University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433363
- Sponsor's protocol ID
- KY2021-260-B
- Status last verified
- Feb 2022
- First submitted
- 22 Jun 2022
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dubois B, Feldman HH, Jacova C, Cummings JL, Dekosky ST, Barberger-Gateau P, Delacourte A, Frisoni G, Fox NC, Galasko D, Gauthier S, Hampel H, Jicha GA, Meguro K, O'Brien J, Pasquier F, Robert P, Rossor M, Salloway S, Sarazin M, de Souza LC, Stern Y, Visser PJ, Scheltens P. Revising the definition of Alzheimer's disease: a new lexicon. Lancet Neurol. 2010 Nov;9(11):1118-27. doi: 10.1016/S1474-4422(10)70223-4. Epub 2010 Oct 9.
PubMed 20934914Sperling RA, Aisen PS, Beckett LA, Bennett DA, Craft S, Fagan AM, Iwatsubo T, Jack CR Jr, Kaye J, Montine TJ, Park DC, Reiman EM, Rowe CC, Siemers E, Stern Y, Yaffe K, Carrillo MC, Thies B, Morrison-Bogorad M, Wagster MV, Phelps CH. Toward defining the preclinical stages of Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):280-92. doi: 10.1016/j.jalz.2011.03.003. Epub 2011 Apr 21.
PubMed 21514248Visser PJ, Tijms B. Brain Amyloid Pathology and Cognitive Function: Alzheimer Disease Without Dementia? JAMA. 2017 Jun 13;317(22):2285-2287. doi: 10.1001/jama.2017.6895. No abstract available.
PubMed 28609518Jack CR Jr, Albert MS, Knopman DS, McKhann GM, Sperling RA, Carrillo MC, Thies B, Phelps CH. Introduction to the recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):257-62. doi: 10.1016/j.jalz.2011.03.004. Epub 2011 Apr 21.
PubMed 21514247Pantoni L, Gorelick P. Advances in vascular cognitive impairment 2010. Stroke. 2011 Feb;42(2):291-3. doi: 10.1161/STROKEAHA.110.605097. Epub 2011 Jan 13. No abstract available.
PubMed 21233478Dichgans M, Leys D. Vascular Cognitive Impairment. Circ Res. 2017 Feb 3;120(3):573-591. doi: 10.1161/CIRCRESAHA.116.308426.
PubMed 28154105Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018.
PubMed 29653606Anderson ND. State of the science on mild cognitive impairment (MCI). CNS Spectr. 2019 Feb;24(1):78-87. doi: 10.1017/S1092852918001347. Epub 2019 Jan 17.
PubMed 30651152Petersen RC, Smith GE, Waring SC, Ivnik RJ, Tangalos EG, Kokmen E. Mild cognitive impairment: clinical characterization and outcome. Arch Neurol. 1999 Mar;56(3):303-8. doi: 10.1001/archneur.56.3.303.
PubMed 10190820Farias ST, Mungas D, Reed BR, Harvey D, DeCarli C. Progression of mild cognitive impairment to dementia in clinic- vs community-based cohorts. Arch Neurol. 2009 Sep;66(9):1151-7. doi: 10.1001/archneurol.2009.106.
PubMed 19752306Tolar M, Abushakra S, Hey JA, Porsteinsson A, Sabbagh M. Aducanumab, gantenerumab, BAN2401, and ALZ-801-the first wave of amyloid-targeting drugs for Alzheimer's disease with potential for near term approval. Alzheimers Res Ther. 2020 Aug 12;12(1):95. doi: 10.1186/s13195-020-00663-w.
PubMed 32787971Staals J, Booth T, Morris Z, Bastin ME, Gow AJ, Corley J, Redmond P, Starr JM, Deary IJ, Wardlaw JM. Total MRI load of cerebral small vessel disease and cognitive ability in older people. Neurobiol Aging. 2015 Oct;36(10):2806-11. doi: 10.1016/j.neurobiolaging.2015.06.024. Epub 2015 Jun 26.
PubMed 26189091Staals J, Makin SD, Doubal FN, Dennis MS, Wardlaw JM. Stroke subtype, vascular risk factors, and total MRI brain small-vessel disease burden. Neurology. 2014 Sep 30;83(14):1228-34. doi: 10.1212/WNL.0000000000000837. Epub 2014 Aug 27.
PubMed 25165388Jessen F, Amariglio RE, Buckley RF, van der Flier WM, Han Y, Molinuevo JL, Rabin L, Rentz DM, Rodriguez-Gomez O, Saykin AJ, Sikkes SAM, Smart CM, Wolfsgruber S, Wagner M. The characterisation of subjective cognitive decline. Lancet Neurol. 2020 Mar;19(3):271-278. doi: 10.1016/S1474-4422(19)30368-0. Epub 2020 Jan 17.
PubMed 31958406
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renji Alzheimer's Disease Neuroimaging Cohort Study
- ClinicalTrials.gov ID
- NCT05433363
- Acronym / sponsor ID
- KY2021-260-B
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 27 Jun 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 study focuses on the population of Alzheimer disease (AD). Based on Aβ(A)-Tau(T)-Vascular(V)-Neurodegeneration(N) (ATV(N))-AD evaluation system of NIA-AA Association, it can accurately diagnose and predict early AD. Positron emission tomography (PET) - magnetic resonance (MR) was used to perform Aβ、Tau molecular imaging, representing A and T in the system respectively; The quantitative detection of glucose metabolism in the brain by fluorodeoxyglucose PET (FDG-PET) can reflect the degree of neuronal damage (N); In addition, PET-MR can be used to synchronously evaluate the patients' vascular comorbidity (SVD load score) (V). Through the preliminary construction of this system, to clarify the central deposition pattern of Aβ、tau protein and the characteristics of FDG metabolism; To clarify the correlation between PET-MR imaging indexes and the progression of early cognitive impairment in AD, and to clarify the role of degeneration and vascular factors in the occurrence and development of AD; To provide a preliminary basis for the subsequent establishment of a molecular imaging model for the prognosis of early AD.
Detailed description
Alzheimer disease (AD) is the most common cognitive impairment disease, which is mainly manifested in memory loss, language function and logical thinking disorder, and ultimately leads to the loss of independent living ability of patients. China has become the country with the largest number of AD patients in the world. At present, it has reached more than 8 million. The AD incidence rate of the elderly over 65 years old is 4%-6%, which seriously affects the health of the elderly. At present, the medicines used in clinical practice are only symptomatic treatment, and have no effect on reversing the course of disease. Studies have shown that AD has a preclinical period of more than 10 years. In this period, patients have specific pathological changes in the brain, but there are no obvious clinical symptoms. However, if the intervention is started after significant cognitive impairment, irreversible changes have taken place in the brain, and the intervention effect is limited. In recent years, many drug clinical studies on ad specific pathophysiological processes have not achieved positive results, which may be one of the important reasons why the study failed to include subjects in the early stage of the disease.
In this context, in 2011, the National Institute of Aging and the Alzheimer's Association (NIA-AA) developed diagnostic criteria for preclinical AD, mild cognitive impairment (MCI) due to AD, and dementia due to AD, which are based on AD specific biomarkers, transform the prenatal diagnosis of AD from clinical symptomatology architecture to central biomarker architecture (gold standard). The latter refers to β Amyloid protein（Aβ), Phosphorylated tau (p-tau) and secondary neurodegenerative injury (neurodegeneration), the so-called AT(N) architecture, in which "A" and "T" are AD specific lesions, and "A" is the earliest landmark change. Through in vivo detection of AD specific central markers to identify AD as early as possible and carry out targeted intervention, it is expected to provide the possibility for AD reversal. On the other hand, it is well known that AD tends to occur in the elderly, and there are often small vessel disease (SVD) coexisting in varying degrees. Both can work together to lead to AD progression. How to define the interaction between the two in the occurrence and progression of disease is also the focus of clinical research on AD. In this context, the 2018 NIA-AA standard update pointed out that the AT(N) architecture can be extended according to the AD comorbidity. For example, if AD is complicated with cerebrovascular disease, AT (N) can be correspondingly extended to ATV (N). The international clinical research based on AT(N) is very limited, while the research on ATV (N) is blank at present.
At present, PET-CT or PET-MR can be used to perform aβ and Tau molecular imaging and FDG-PET can reflect the damage degree of neurons through the quantitative detection of brain glucose metabolism, and realize the early accurate individual diagnosis of AD based on AT(N) architecture. PET-MR can also realize the simultaneous evaluation of patients' vascular comorbidity. For example, the SVD load score of MRI images is often used in clinical evaluation. Therefore, PET-MR research is carried out on patients with AD-MCI, It can realize the early accurate identification and comprehensive evaluation of AD based on AT(V) N architecture, and help to explore the contribution of degenerative factors and vascular load to the occurrence and development of cognition. It is a hot spot in clinical research in the field of AD at present, and it is in urgent need of breakthrough. At present, the research on the central biomarkers of early clinical AD is very limited, especially the longitudinal study which is combination of Aβ、 Tau and FDG multimodal PET images.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal control | – | –normal, cognitive test normal, PET(-) |
| cognitive disorder due to AD | – | –PET Aβ（+），MCI-AD and AD dementia |
| cognitive disorder NOT due to AD | – | –PET Aβ（-），MCI or dementia not due to AD |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care population; primary care clinic; memory clinic
Key inclusion criteria (2 listed)
- 1) Age: 50-75 years old; 2) complaints of memory decline; 3) Education≥ 6 years; 4) Be able to cooperate with the whole neuropsychological examinations; 5) No PET-MRI or brain MRI contraindications; 6) Sign informed consent.
- normal control: 1) Age: 50-75 years old; 2) No complaints of memory decline; 3) Mini-Mental State Examination (MMSE) ≥ 26 points; 4) Education years ≥ 6 years; 5) Be able to cooperate with a full set of neuropsychological examinations; 6) No PET-MRI or brain MRI contraindications; 7) Sign informed consent.
Key exclusion criteria (1 listed)
- 1) Serious mental illness; 2) Severe depression: Hamilton Depression Scale (HAMD-17) scores ≥ 24; 3) Serious heart, liver, kidney and other important organ diseases; 4) PET-MRI or brain MRI contraindications
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
To establish AD accurate evaluation model
Time frame: from 2022-02 to 2022-08
Using PET-MR to establish AD accurate evaluation model based on ATV (N) evaluation system
to analyze the correlation of PET-MR imaging indicators in AD progression
Time frame: From 2022-08 to 2023-02
PET-MR imaging indicators were used to analyze the correlation between the progress of cognitive impairment in AD and to prepare for the follow-up study
To clarify the role of degeneration and vascular factors in the development of cognition
Time frame: From 2022-08 to 2023-02
To clarify the role of degeneration and vascular factors in the development of cognition
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Background: PubMed 20934914Dubois B, Feldman HH, Jacova C, Cummings JL, Dekosky ST, Barberger-Gateau P, Delacourte A, Frisoni G, Fox NC, Galasko D, Gauthier S, Hampel H, Jicha GA, Meguro K, O'Brien J, Pasquier F, Robert P, Rossor M, Salloway S, Sarazin M, de Souza LC, Stern Y, Visser PJ, Scheltens P. Revising the definition of Alzheimer's disease: a new lexicon. Lancet Neurol. 2010 Nov;9(11):1118-27. doi: 10.1016/S1474-4422(10)70223-4. Epub 2010 Oct 9.
- Background: PubMed 21514248Sperling RA, Aisen PS, Beckett LA, Bennett DA, Craft S, Fagan AM, Iwatsubo T, Jack CR Jr, Kaye J, Montine TJ, Park DC, Reiman EM, Rowe CC, Siemers E, Stern Y, Yaffe K, Carrillo MC, Thies B, Morrison-Bogorad M, Wagster MV, Phelps CH. Toward defining the preclinical stages of Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):280-92. doi: 10.1016/j.jalz.2011.03.003. Epub 2011 Apr 21.
- Background: PubMed 28609518Visser PJ, Tijms B. Brain Amyloid Pathology and Cognitive Function: Alzheimer Disease Without Dementia? JAMA. 2017 Jun 13;317(22):2285-2287. doi: 10.1001/jama.2017.6895. No abstract available.
- Background: PubMed 21514247Jack CR Jr, Albert MS, Knopman DS, McKhann GM, Sperling RA, Carrillo MC, Thies B, Phelps CH. Introduction to the recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):257-62. doi: 10.1016/j.jalz.2011.03.004. Epub 2011 Apr 21.
- Background: PubMed 21233478Pantoni L, Gorelick P. Advances in vascular cognitive impairment 2010. Stroke. 2011 Feb;42(2):291-3. doi: 10.1161/STROKEAHA.110.605097. Epub 2011 Jan 13. No abstract available.
- Background: PubMed 28154105Dichgans M, Leys D. Vascular Cognitive Impairment. Circ Res. 2017 Feb 3;120(3):573-591. doi: 10.1161/CIRCRESAHA.116.308426.
- Background: PubMed 29653606Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018.
- Background: PubMed 30651152Anderson ND. State of the science on mild cognitive impairment (MCI). CNS Spectr. 2019 Feb;24(1):78-87. doi: 10.1017/S1092852918001347. Epub 2019 Jan 17.
- Background: PubMed 10190820Petersen RC, Smith GE, Waring SC, Ivnik RJ, Tangalos EG, Kokmen E. Mild cognitive impairment: clinical characterization and outcome. Arch Neurol. 1999 Mar;56(3):303-8. doi: 10.1001/archneur.56.3.303.
- Background: PubMed 19752306Farias ST, Mungas D, Reed BR, Harvey D, DeCarli C. Progression of mild cognitive impairment to dementia in clinic- vs community-based cohorts. Arch Neurol. 2009 Sep;66(9):1151-7. doi: 10.1001/archneurol.2009.106.
- Background: PubMed 32787971Tolar M, Abushakra S, Hey JA, Porsteinsson A, Sabbagh M. Aducanumab, gantenerumab, BAN2401, and ALZ-801-the first wave of amyloid-targeting drugs for Alzheimer's disease with potential for near term approval. Alzheimers Res Ther. 2020 Aug 12;12(1):95. doi: 10.1186/s13195-020-00663-w.
- Background: PubMed 26189091Staals J, Booth T, Morris Z, Bastin ME, Gow AJ, Corley J, Redmond P, Starr JM, Deary IJ, Wardlaw JM. Total MRI load of cerebral small vessel disease and cognitive ability in older people. Neurobiol Aging. 2015 Oct;36(10):2806-11. doi: 10.1016/j.neurobiolaging.2015.06.024. Epub 2015 Jun 26.
- Individual participant dataSharing planned: Undecided
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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.
Qun Xu, professor principal investigator
Renji Hospital, Shanghai Jiaotong University of Medicine
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 RenJi Hospital at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 27 Jun 2022. 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 China. 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?
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?
To establish AD accurate evaluation model (time frame: from 2022-02 to 2022-08). The study lists 3 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 NCT05433363, which also lists 14 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 27 Jun 2022; AzTrials last refreshed its copy on 6 Nov 2026.