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Clinical study of 123i and 18F labelled [6muriodoMuth2-(49murdimethylamino -) phenyl-imidazo [1Zhuo 2-alpha] pyridine] beta-amyloid specific molecular probe in early diagnosis of Alzheimer's disease

Clinical study of 123i and 18F labelled [6muriodoMuth2-(49murdimethylamino -) phenyl-imidazo [1Zhuo 2-alpha] pyridine] beta-amyloid specific molecular probe in early diagnosis of Alzheimer's disease

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000035456
Enrollment
Unknown
Registered
2020-08-11
Start date
2020-08-31
Completion date
Unknown
Last updated
2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's disease

Interventions

Gold Standard:1. MMSE scale
2. Head MRI
3.A beta 1-40, A beta 1-42
4. Standard uptake value (SUV)
5. Distribution volume ratio (DVR)
6. Binding potential(BPND).
Index test:beta-amyloid&#32

Sponsors

Xinhua Hospital Affliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. A patient with Alzheimer's disease; a patient who is clinically diagnosed as Alzheimer's disease and preclinical Alzheimer's disease; 2. Healthy subjects: healthy people who exclude diseases such as other neurological diseases; 3. The hematopoietic function of bone marrow and the function of liver and kidney were normal; 3.1 White blood cell count > 3000/uL, neutrophil count >=1500/uL, platelet >=1000000/uL, hemoglobin >=9 g/dL. 3.2Serum creatinine =60mL/min; 3.3 Blood bilirubin < 1.25 times normal upper limit, glutamic pyruvic transaminase and glutamic oxaloacetic transaminase < 2.5 times normal upper limit; 4. Be able to follow the research plan and follow up on a regular basis; 5. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria for patients with Alzheimer's disease (supplementary blood tests and auxiliary tests such as brain MRI to rule out other causes of cognitive impairment or dementia or concomitant diseases such as vascular damage). Other diseases sufficient to cause related symptoms: (1) depression; (2) cerebrovascular disease; (3) poisoning, inflammation or metabolic disorder. 2. Exclusion criteria for healthy subjects: healthy people with neurological diseases and tumors / hypertension / diabetes were excluded; 3. abnormal blood routine and abnormal liver and kidney function; 4. Concomitant diseases are not suitable for radiopharmaceutical treatment; 5. Other conditions (religion, psychology, etc.) affect informed consent, compliance with research programs or failure to follow up on time.

Design outcomes

Primary

MeasureTime frame
MMSE scale;A beta 1-40, A beta 1-42;Standard uptake value;Distribution volume ratio;Binding potential;Head MRI;

Countries

China

Contacts

Public ContactWang Hui

Xinhua Hospital Affliated to Shanghai Jiaotong University School of Medicine

wanghui@xinhuamed.com.cn+86 13651605869

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026