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NCT03657732Toboroz

The Chinese Familial Alzheimer's Network

A Multi-center Longitudinal Cohort Study of Familial Alzheimer's Disease in China

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. márc. 23.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

This research will establish and continuously improve the FAD research network in conjunction with multi-center institutions nationwide. By collecting information on the family's demography, genetics, neuropsychology, neuroimaging, biomarkers and other information, we can understand the current FAD population in China, clarify the genetic characteristics, pathogenesis, disease characteristics and diagnosis and treatment status of AD in China; which will lay the foundation for ameliorating clinical diagnosis and treatment, establishing a Chinese FAD clinical database and an international cooperative research platform. 1. To set up a multi-center, nationwide FAD research network and database platform in China 2. To clarify the epidemiological characteristics of FAD in China. 3. To clarify the genetic characteristics of FAD in China. 4. To clarify the clinical characteristics and disease development laws of FAD. 5. To discover and verify the early diagnosis biomarkers of AD. 6. To establish a genetic counseling model.

Állapot (regiszter)
Toboroz
Vizsgálattípus
Megfigyeléses
Résztvevők száma
40000 (tervezett)
Első benyújtás
2018. aug. 21.
Kezdés
2005. jan. 10.
Elsődleges befejezés
2038. jan. 1.
Fő szponzor
Capital Medical University
Betegségek
Alzheimer-kór
NCT-szám
NCT03657732

Mit vállalsz

  • Vizsgálat típusa: Megfigyeléses
  • Tervezett résztvevők: 40000
  • 2005. jan. 10. és az elsődleges befejezés (2038. jan. 1.) között
  • 65 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

Ki nem vehet részt

Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.

Más betegség

  • Dementia caused by other factors such as depression, other psychiatric illnesses, thyroid dysfunction, encephalitis, multiple sclerosis, brain trauma, brain tumor, syphilis, acquired immunodeficiency syndrome (AIDS), Creutzfeldt-Jakob disease and other types of dementias such as vascular dementia (VaD), frontotemporal dementia (FTD), dementia with Lewy bodies (DLB), and Parkinson's dementia (PDD);
  • Severe circulatory, respiratory, urinary, digestive, hematopoietic diseases (such as unstable angina, uncontrollable asthma, active gastric bleeding) and cancer;
  • Participant has severe psychiatric illness or severe dementia that would interfere in completing initial and follow-up clinical assessments;
  • Participant has a history of alcoholism or drug abuse;
  • MRI Exclusion Criteria: electronic and magnetic metal implants such as pacemakers, artificial heart valve, metal prosthesis, metal joint, etc.; metallic foreign body in the eye; aneurysm clips in the brain.
    • Normal control group
  • Subjects with a history of cerebral infarction, traumatic brain injury or related manifestations in MRI;
  • Other neurological diseases that can cause brain dysfunction (such as depression, brain tumor, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal intracranial pressure hydrocephalus, etc.);
  • Other systemic diseases that can cause cognitive impairment (such as liver, renal and thyroid insufficiency, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.);
  • Suffering from a disease that cannot be combined with a cognitive examination;

Laborértékek

  • MRI and laboratory tests do not support or rule out a diagnosis of AD;
  • Lumbar puncture exclusion criteria:coagulation disorders or platelet counts < 100,000 cells/μL, lumbar surgery within the last 6 months prior to lumbar puncture that interferes with anatomy of the inter-vertebral spaces, History of chronic or repeated CSF leakage following previous LP(s);

Egyéb

  • Pregnant or lactating women;
  • No reliable informant;
  • Subjects with abnormal MMSE or MoCA scores;
  • Mental and neurodevelopmental retardation;
  • Contraindications to MRI;
  • Refuse to draw blood;
  • Refuse to sign the informed consent at baseline.

Kiket keres a vizsgálat

  • Written informed consent obtained from the participant or a legal guardian prior to any study-related procedures;
  • At least two first-degree relatives in a family have AD (clinically or by testing),and at least 3 out of 2 generations are patients;
  • At least one family member with normal cognitive function (the age should be greater than the average age of onset of the family);
  • Pedigrees carrying FAD pathogenic genes (APP/PSEN1/PSEN2);
  • People in this family >18 years old can be recruited;
  • Participant is cognitively normal or demented but not reaching bedridden level;
  • Participants are able to provide two reliable informants who can provide clinical information;
  • Dementia is diagnosed according to the criteria described by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-R );
  • The diagnosis of AD is made using the National Institute of Neurologic and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA ) or National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria ;
  • The diagnosis of MCI is made according to Petersen criteria and the classification is according to the method of Lopez et al.
  • Aged 18 (inclusive) or above;
  • Normal MMSE and MoCA evaluations. MMSE>19 points for illiteracy, >24 points for those educated less than 7 years, >27 points for those educated equal to or more than 7 years. MoCA>13 points for illiteracy, >19 points for those educated less than 7 years, >24 points for those educated equal to or more than 7 years.

A regiszterben nem jelölt feltételek

  • Familial Alzheimer's disease group

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (65)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Changda Hospital, AnshanAnshanKínaToboroz
Baotou Central HospitalBaotouKínaToboroz
China-Japan friendship Hospital of Jilin universityChangchunKínaToboroz
The First Hospital of Jilin UniversityChangchunKínaToboroz
Beijing Geriatric HospitalChangpingKínaToboroz
China-Japan Friendship HospitalChaoyangKínaToboroz
Beijing Chao Yang HospitalChaoyangKínaToboroz
The First Affiliated Hospital of Dalian Medical UniversityDalianKínaToboroz
Affiliated Zhongshan Hospital of Dalian UniversityDalianKínaToboroz
Dongfang Hospital Affiliated to Beijing University of Chinese MedicineFengtaiKínaToboroz
Fujian Medical University Union HospitalFujianKínaToboroz
Guangzhou Psychiatric HospitalGuangzhouKínaToboroz
The Affiliated Hospital of Guizhou Medical UniversityGuiyangKínaToboroz
First Affiliated Hospital of Harbin Medical UniversityHaerbinKínaToboroz
Peking University Third HospitalHaidianKínaToboroz
Fu Xing Hospital, Capital Medical UniversityHaidianKínaToboroz
Chinese PLA General HospitalHaidianKínaToboroz
Handan Central HospitalHandanKínaToboroz
Shao Yifu Hospital of Zhejiang Medical UniversityHangzhouKínaToboroz
Zhejiang Provincial People's HospitalHangzhouKínaToboroz
First Affiliated Hospital of Zhejiang UniversityHangzhouKínaToboroz
The First Affiliated Hospital of Anhui Medical UniversityHefeiKínaToboroz
Shanghai Changzheng HospitalHuangpuKínaToboroz
Qilu Hospital of Shandong UniversityJinanKínaToboroz
Shandong Provincial HospitalJiningKínaToboroz
Kaifeng Central HospitalKaifengKínaToboroz
Ruijin HospitalLuwanKínaToboroz
Jiangxi Provincial People's HospitalNanchangKínaToboroz
Affiliated Hospital of North Sichuan Medical CollegeNanchongKínaToboroz
First Affiliated Hospital of Guangxi Medical UniversityNanningKínaToboroz
Nantong University Affiliated HospitalNantongKínaToboroz
Ningbo City Medical Treatment Center Lihuili HospitalNingboKínaToboroz
RenJi HospitalPutongKínaToboroz
QingDao Municipal HospitalQingdaoKínaToboroz
Qilu Hospital of Shandong University (Qingdao)QingdaoKínaToboroz
The Affiliated Hospital of Qingdao UniversityQingdaoKínaToboroz
First Hospital of China Medical UniversityShenyangKínaToboroz
First Hospital of Shijiazhuang CityShijiazhuangKínaToboroz
Subei People's Hospital of JiangsuSubeiKínaToboroz
The 88th Hospital of PLATai’anKínaToboroz
The First Affiliated Hospital of Shanxi Medical UniversityTaiyuanKínaToboroz
Tangshan Worker's HospitalTangshanKínaToboroz
Traditional Chinese Medicine Hospital of Xinjiang Autonomous RegionÜrümqiKínaToboroz
First Affiliated Hospital of Wenzhou Medical UniveristyWenzhouKínaToboroz
Wuhan University Zhongnan HospitalWuhanKínaToboroz
The Third Xiangya Hospital of Central South UniversityWuhanKínaToboroz
Tongji HospitalWuhanKínaToboroz
People's Hospital Affiliated Hubei Medical UniversityWuhanKínaToboroz
Xiangya Hospital of Central South UniversityWuhanKínaToboroz
Tang-Du HospitalXi’anKínaToboroz
First Affiliated Hospital Xi'an Jiaotong UniversityXi’anKínaToboroz
Tianjin Huanhu HospitalXianshuiguKínaToboroz
Tianjin Medical University General HospitalXiaobailouKínaToboroz
Peking University First HospitalXichengKínaToboroz
Peking Union Medical College HospitalXichengKínaToboroz
Mineral General Hospital, XuzhouXuzhouKínaToboroz
The People's Hospital of NingxiaYinchuanKínaToboroz
General Hospital of Ningxia Medical UniversityYinchuanKínaToboroz
The Second Affiliated Hospital of Chongqing Medical UniversityYuzhongKínaToboroz
Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityYuzhongKínaToboroz
People's Hospital of ZhengzhouZhengzhouKínaToboroz
Henan Provincial People's HospitalZhengzhouKínaToboroz
Hebei General HospitalZhijiazhuangKínaToboroz
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityZhongshanKínaToboroz
Zigong First People's HospitalZigongKínaToboroz

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