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.
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.
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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
Helyszínek (65)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Changda Hospital, Anshan | Anshan | Kína | Toboroz |
| Baotou Central Hospital | Baotou | Kína | Toboroz |
| China-Japan friendship Hospital of Jilin university | Changchun | Kína | Toboroz |
| The First Hospital of Jilin University | Changchun | Kína | Toboroz |
| Beijing Geriatric Hospital | Changping | Kína | Toboroz |
| China-Japan Friendship Hospital | Chaoyang | Kína | Toboroz |
| Beijing Chao Yang Hospital | Chaoyang | Kína | Toboroz |
| The First Affiliated Hospital of Dalian Medical University | Dalian | Kína | Toboroz |
| Affiliated Zhongshan Hospital of Dalian University | Dalian | Kína | Toboroz |
| Dongfang Hospital Affiliated to Beijing University of Chinese Medicine | Fengtai | Kína | Toboroz |
| Fujian Medical University Union Hospital | Fujian | Kína | Toboroz |
| Guangzhou Psychiatric Hospital | Guangzhou | Kína | Toboroz |
| The Affiliated Hospital of Guizhou Medical University | Guiyang | Kína | Toboroz |
| First Affiliated Hospital of Harbin Medical University | Haerbin | Kína | Toboroz |
| Peking University Third Hospital | Haidian | Kína | Toboroz |
| Fu Xing Hospital, Capital Medical University | Haidian | Kína | Toboroz |
| Chinese PLA General Hospital | Haidian | Kína | Toboroz |
| Handan Central Hospital | Handan | Kína | Toboroz |
| Shao Yifu Hospital of Zhejiang Medical University | Hangzhou | Kína | Toboroz |
| Zhejiang Provincial People's Hospital | Hangzhou | Kína | Toboroz |
| First Affiliated Hospital of Zhejiang University | Hangzhou | Kína | Toboroz |
| The First Affiliated Hospital of Anhui Medical University | Hefei | Kína | Toboroz |
| Shanghai Changzheng Hospital | Huangpu | Kína | Toboroz |
| Qilu Hospital of Shandong University | Jinan | Kína | Toboroz |
| Shandong Provincial Hospital | Jining | Kína | Toboroz |
| Kaifeng Central Hospital | Kaifeng | Kína | Toboroz |
| Ruijin Hospital | Luwan | Kína | Toboroz |
| Jiangxi Provincial People's Hospital | Nanchang | Kína | Toboroz |
| Affiliated Hospital of North Sichuan Medical College | Nanchong | Kína | Toboroz |
| First Affiliated Hospital of Guangxi Medical University | Nanning | Kína | Toboroz |
| Nantong University Affiliated Hospital | Nantong | Kína | Toboroz |
| Ningbo City Medical Treatment Center Lihuili Hospital | Ningbo | Kína | Toboroz |
| RenJi Hospital | Putong | Kína | Toboroz |
| QingDao Municipal Hospital | Qingdao | Kína | Toboroz |
| Qilu Hospital of Shandong University (Qingdao) | Qingdao | Kína | Toboroz |
| The Affiliated Hospital of Qingdao University | Qingdao | Kína | Toboroz |
| First Hospital of China Medical University | Shenyang | Kína | Toboroz |
| First Hospital of Shijiazhuang City | Shijiazhuang | Kína | Toboroz |
| Subei People's Hospital of Jiangsu | Subei | Kína | Toboroz |
| The 88th Hospital of PLA | Tai’an | Kína | Toboroz |
| The First Affiliated Hospital of Shanxi Medical University | Taiyuan | Kína | Toboroz |
| Tangshan Worker's Hospital | Tangshan | Kína | Toboroz |
| Traditional Chinese Medicine Hospital of Xinjiang Autonomous Region | Ürümqi | Kína | Toboroz |
| First Affiliated Hospital of Wenzhou Medical Univeristy | Wenzhou | Kína | Toboroz |
| Wuhan University Zhongnan Hospital | Wuhan | Kína | Toboroz |
| The Third Xiangya Hospital of Central South University | Wuhan | Kína | Toboroz |
| Tongji Hospital | Wuhan | Kína | Toboroz |
| People's Hospital Affiliated Hubei Medical University | Wuhan | Kína | Toboroz |
| Xiangya Hospital of Central South University | Wuhan | Kína | Toboroz |
| Tang-Du Hospital | Xi’an | Kína | Toboroz |
| First Affiliated Hospital Xi'an Jiaotong University | Xi’an | Kína | Toboroz |
| Tianjin Huanhu Hospital | Xianshuigu | Kína | Toboroz |
| Tianjin Medical University General Hospital | Xiaobailou | Kína | Toboroz |
| Peking University First Hospital | Xicheng | Kína | Toboroz |
| Peking Union Medical College Hospital | Xicheng | Kína | Toboroz |
| Mineral General Hospital, Xuzhou | Xuzhou | Kína | Toboroz |
| The People's Hospital of Ningxia | Yinchuan | Kína | Toboroz |
| General Hospital of Ningxia Medical University | Yinchuan | Kína | Toboroz |
| The Second Affiliated Hospital of Chongqing Medical University | Yuzhong | Kína | Toboroz |
| Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Yuzhong | Kína | Toboroz |
| People's Hospital of Zhengzhou | Zhengzhou | Kína | Toboroz |
| Henan Provincial People's Hospital | Zhengzhou | Kína | Toboroz |
| Hebei General Hospital | Zhijiazhuang | Kína | Toboroz |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Zhongshan | Kína | Toboroz |
| Zigong First People's Hospital | Zigong | Kína | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.