Renji Alzheimer's Disease Neuroimaging Cohort Study

NCT05433363 | Unknown DMC

• 1 other identifier: KY2021-260-B
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (3)

• To establish AD accurate evaluation model

  Using PET-MR to establish AD accurate evaluation model based on ATV (N) evaluation system

  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

  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

  From 2022-08 to 2023-02

Study Arms (3)

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

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care population; primary care clinic; memory clinic

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital,Shanghai Jiao Tong University School of Medicine

Shanghai, 200127, China

Location

Related Publications (14)

• 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.

  PMID: 20934914 BACKGROUND

• Sperling 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.

  PMID: 21514248 BACKGROUND

• Visser 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.

  PMID: 28609518 BACKGROUND

• Jack 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.

  PMID: 21514247 BACKGROUND

• Pantoni 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.

  PMID: 21233478 BACKGROUND

• Dichgans M, Leys D. Vascular Cognitive Impairment. Circ Res. 2017 Feb 3;120(3):573-591. doi: 10.1161/CIRCRESAHA.116.308426.

  PMID: 28154105 BACKGROUND

• Jack 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.

  PMID: 29653606 BACKGROUND

• Anderson 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.

  PMID: 30651152 BACKGROUND

• Petersen 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.

  PMID: 10190820 BACKGROUND

• Farias 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.

  PMID: 19752306 BACKGROUND

• Tolar 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.

  PMID: 32787971 BACKGROUND

• Staals 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.

  PMID: 26189091 BACKGROUND

• Staals 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.

  PMID: 25165388 BACKGROUND

• Jessen 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.

  PMID: 31958406 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

serum retention in -80℃ fridge for ApoE4 gene test etc

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Qun Xu, professor

  Renji Hospital, Shanghai Jiaotong University of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 27, 2022
• Study Start: February 14, 2022
• Primary Completion: December 1, 2022
• Study Completion: February 1, 2023
• Last Updated: June 27, 2022

Record last verified: 2022-02

Locations

CN (1)