Young (age of diagnosis = 70 years) patients with (suspicion of) dementia with at least some doubt about etiological diagnosis.
Conditions
Sponsors
VU University Medical Center (VUmc)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent; - (suspicion of) dementia diagnosis; - Weight >50 kg; - Mini Mental State Examination score = 18. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: Patients who - are considered medically unstable; - require additional laboratory tests or workup between enrolment and completion of the PET scan; - have a clinically significant infectious disease, including Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV) infection; - 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; - have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the PET scan; - 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 ß-hCG at the time of screening and negative urine ß-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; - have donated blood within 3 months before the scan day; - have metal objects in or around the body (braces, pacemaker, metal fragments).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To investigate the clinical value of [18F]Flutemetamol PET in patients with young onset dementia in terms of a. change in (level of confidence of) diagnosis; b. impact on patient healthcare management; c. diagnostic accuracy of final diagnosis at 2 years follow-up; d. cost-effectiveness. ;Secondary Objective: 1. To assess the concordance of [18F]Flutemetamol PET with established biomarkers acquired from CSF and MRI; 2. To assess the prognostic value of [18F]Flutemetamol PET. ;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: Evaluation wil be executed after the last patient’s last visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The concordance of [18F]Flutemetamol PET with CSF markers (Aß 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. ;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Countries
Netherlands
Contacts
Public ContactAlzheimercentrum
VU University Medical Center (VUmc)
Outcome results
None listed