Evaluation of 18F-AV-1451 kinetic modeling in patients in Alzheimer's disease and healthy controls

Evaluation of 18F-AV-1451 kinetic modeling in patients in Alzheimer's disease and healthy controls - Tau-Image

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44604

Enrollment

Registered

2015-07-28

Start date

2015-08-13

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Alzheimer's Disease dementia

Interventions

Name of compound: 18F-AV-1451(also known as [F-18]T807) Dose: 240 MBq (6.5mCi) Route of Administration: Intravenous (IV) bolus

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy Control Subjects: 1. Male or female * 50 years of age 2. No evidence of cognitive impairment;AD subjects: 1. Male or female * 50 years of age 2. Clinical diagnosis of probable Alzheimer's Disease (AD) 3. MMSE * 18 4. PET or CSF biomarker data supports that the subject is amyloid positive

Exclusion criteria

Exclusion criteria: All subjects: 1. Current clinically significant psychiatric condition 2. Normal hemoglobin * 8 in males or * 7 in females 3. Possible pregnancy 4. MRI evidence of brain structural abnormality 5. Relevant history of drug allergy or hypersensivity 6. Current clinically significant cardiovascular disease, abnormalities on screening ECG (e.g. QTc >450msec) 7. Donated blood

Design outcomes

Primary

Measure	Time frame
Quantitative Specific binding of18F-AV-1451 in the brain. Simplified parametric methods. Test-retest stability	—

Secondary

Measure	Time frame
relation with cognition	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)