Alzheimer's Disease dementia of the Alzheimer type
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Written informed consent; - age *80 years; - weight >50 kg; - Mini Mental State Examination score * 18.
Exclusion criteria
Exclusion criteria: Patients who - are considered medically unstable; - require additional laboratory tests or workup between enrolment and completion of the PET scan; - are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days prior to the PET scan; - have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, *-secretase or *-secretase inhibitor) unless it can be documented that the subject received only placebo during the course of the trial; - are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Females of childbearing potential must not be pregnant (negative serum *-hCG at the time of screening and negative urine *-hCG on the day of imaging) or breast feeding at screening. Females 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 [18F]Flutemetamol; - are claustrophobic; - have abnormalities on MRI, other than white matter changes or an incidental small lacunar lesion, which may affect visual reading of Flutemetamol PET.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome measure is the clinical value of [18F]Flutemetamol PET, which can be subdivided into four outcome measures. First, the change in (the level of confidence in) the diagnosis as assessed by the clinician after the disclosure of the PET results will be measured. Secondly, the impact on future patient management as measured using additional ancillary investigations, prescription of medication and use of health care will be measured. Third, the diagnostic accuracy for final diagnosis defined by a consensus panel of clinicians at 2 years follow-up (used as a reference diagnosis) will be estimated. Fourth, cost-effectiveness will be assessed using questionnaires that enables quality of life and care related costs calculation. | — |
Secondary
| Measure | Time frame |
|---|---|
| The concordance of [18F]Flutemetamol PET with CSF markers (A* 1-42, total tau and p-tau 181) and MRI markers (atrophy medial temporal lobe) will be assessed by binary rating (e.g. *normal* or *abnormal*) for each of these measures. Furthermore, the prognostic value of [18F]Flutemetamol will be measured using (repeated) cognitive measures (Mini Mental State Examination (MMSE) and the Cambridge Cognitive Test (CAMCOG)) obtained at baseline and at 1 and 2 year follow-up. | — |
Countries
Netherlands
Outcome results
None listed