F03 F00.0 F00.1 F00.2 F00.9
Conditions
Interventions
Group 1: The intervention is the performance of amyloid PET and the guideline-compliant diagnostic and therapeutic management based on the findings.
Group 2: The comparative intervention is guideline-
Sponsors
Deutsches Zentrum für Neurodegenerative Erkrankungen e. V.
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: - Mild to moderate dementia syndrome. - Clinical Dementia Rating Scale (CDR-SB) greater than 0.5 and less than 3.0 and Mini-Mental Status Examination (MMSE) greater than 10 - Unclear diagnosis of dementia or uncertain diagnosis of Alzheimer's disease (diagnostic certainty less than 85 percent). - At least 15 percent probability of Alzheimer's disease, i.e., Alzheimer's disease cannot be excluded with certainty. - Diagnosis by examination of the cerebrospinal fluid is not possible because a) the patient has a contraindication to CSF puncture, b) the patient refuses CSF puncture or c) the diagnosis remains unclear after CSF puncture. - Patients who would agree in principle to undergo amyloid PET diagnostics and are willing to receive the results if randomised to the amyloid PET arm. - Written informed consent, either by the patient or the legal representative according to the presumed will of the patient - Accompanied by an authorised/qualified informant - Patients with valid insurance cover from a German statutory health insurance company
Exclusion criteria
Exclusion criteria: - Severe dementia (CDR score equal to 3 and/or an MMST score less than or equal to 10). - Mild cognitive impairment, CDR score less than or equal to 0.5, absence of cognitive impairment relevant to daily living - Patients in whom radiation exposure must be avoided - Pregnancy or breastfeeding at the time of the amyloid PET measurement (for women who are less than 12 months postmenopausal, a pregnancy test is carried out before the amyloid PET-measurement) - Patients who are currently participating in another clinical trial with investigational medication or within 5 half-lives of the investigational medication of another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ability to manage activities of daily living as measured by the Amsterdam Instrumental Activities of Daily Living Questionnaire© (A-IADL-Q) score 78 weeks after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of adverse effects of amyloid PET examination in a period of 2 weeks after the amyloid PET examination was performed. Measured via the specialist physician at the study site: - 26 weeks after randomization: change in etiologic dementia diagnosis, change in diagnostic certainty, change in diagnostic and therapeutic (especially medication administration or discontinuation) management. - Throughout the trial period: occurrence of adverse and serious adverse events (SAEs) and adverse drug reactions (ARs), mortality (also in the context of the safety assessment) Measured via patients and/or relatives by investigators blinded to the study condition: - 26, 52, 78, and 104 weeks after randomization: cognitive performance (ADAS-cog, MMSE, CDR-SB), quality of life, incl. health-related quality of life (QOL-AD scale), need for full inpatient or institutionalized outpatient care (institutionalization) or intensification of institutionalized outpatient care, and total duration and frequency of unplanned inpatient stays within one year (Questionnaire on Utilization of Medical and Nursing Services in Old Age [FIMA]). Measured via the Medical Review: Use of potentially inappropriate medications: PRISCUS list. | — |
Countries
Germany
Contacts
Public ContactStefan Teipel
DZNE Rostock/ Greifswald und Universitätsmedizin Rostock, Klinik und Poliklinik für Psychosomatik und Psychotherapeutische Medizin, Zentrum für Nervenheilkunde
Outcome results
None listed