NL-OMON47767
Completed
Phase 4
The clinical prognostic value of amyloid imaging with [18F]AV-45 in a subjects with subjective complaints - Clinical prognostic value [18F]AV-45
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Alzheimer's Disease
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 280
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- age \>45
- •\- Written informed consent
- •\- Weight \>50 kg , \- Able to tolerate 70\-minute scanning
- •\- No objective cognitive impairment (i.e. no diagnosis of dementia, mild cognitive impairment, psychiatric or neurological disorder explaining cognitive complaints).
- •\- MMSE \>\<\= 18
Exclusion Criteria
- •Patients who
- •1\. Have a current a major psychiatric disorder, such as psychosis, schizophrenia, severe personality disorder or depression with vital signs, abuse of alcohol or other substances. Or patients who have a neurological disorder, such as Parkinson's disease, symptomatic stroke, mental retardation.
- •2\. Are women of childbearing potential who are not surgically sterile, not refraining
- •from sexual activity or not using reliable methods of contraception. Women of
- •childbearing potential must not be pregnant (negative urine \*\-hCG at the time of
- •screening and negative urine \*\-hCG on the day of imaging) or breast feeding at
- •screening. Women must avoid becoming pregnant, and must agree to refrain from
- •sexual activity or to use reliable contraceptive methods such as prescribed birth
- •control or IUD for 24 hours following administration of florbetapir (18F);
- •3\. Have a relevant history of severe drug allergy or hypersensitivity (relevant severe
Outcomes
Primary Outcomes
Not specified
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