G20 G30.9
Conditions
Interventions
Group 1: high-risk cohort
study plan:
phase 1a (Online Survey):
Participants fill out a specially designed questionnaire online, which determines risk factors and prodromal markers determined in pr
investigations include structured interview, validated questionnaires, cognitive screening (MoCA), physical examination, sampling of blood, saliva, urine, stool, cerebra-spinal fluid, skin, nasal lava
Sponsors
Paracelsus-Elena-Klinik Kassel
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: Phase 1a (Online Survey): (a) registered residents of the city of Kassel and the district of Kassel (b) male or female age 50 till 80 (c) consent to study participation via WebConsent form Phase 1b (Smell Assessment) (a) participants of phase 1 with highest risk according to the screening algorithm with subjective hyposmia (n=600) or subjective normosmia (n=2000) (b) consent to be contacted by the study team for follow-up investigation via WebConsent form Phase 2 (In-Person Visits) (a) participants of phase 1a with lowest risk according to the risk assessment of the online survey (b) participants of phase 1b with pathological olfactory function test (defined as at or below the 15th percentile by age and gender determined by UPSIT®) (c) consent to be contacted by the study team for invitation to in-person investigations via WebConsent form (d) written informed consent to participate in more in-depth examinations after consultation at the beginning of the in-person visit
Exclusion criteria
Exclusion criteria: Phase 1a (Online Survey) (a) lack of consent Phase 1b (Smell Assessment) (a) subjects with previously diagnosed movement disorder (idiopathic or atypical PD) or diagnosed dementia (b) subjects with clinically relevant diseases of the central nervous system (multiple sclerosis, severe vascular encephalopathy, Korsakoff syndrome, etc.) (c) subjects who take medication that can cause drug-induced PD (e.g. Haloperidol, Risperdal, etc.) Phase 2 (In-Person Visits) (a) subjects with previously diagnosed movement disorder (idiopathic or atypical PD) or diagnosed dementia or high clinical suspicion of these conditions (in the opinion of the investigator) b) subjects with clinically relevant diseases of the central nervous system (multiple sclerosis, severe vascular encephalopathy, Korsakoff syndrome, etc.) or high clinical suspicion of these conditions (in the opinion of the investigator) c) subjects who take medication that can cause drug-induced PD (e.g. Haloperidol, Risperdal, etc.) d) inability to provide written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ONLINE SURVEY: The primary goal of phase 1a is the questionnaire-based characterization of the general population between the ages of 50 and 80 with regard to risk factors for prodromal PD and/or dementia. SMELL ASSESSMENT: The primary goal of phase 1b is the additional characterization of olfactory function of subjects with highest risk according to the results of phase 1a. IN-PERSON VISITS: The primary goal of phase 2 is the evaluation of the screening module of phase 1a with regard to specificity / validity, if necessary, optimization of the module. | — |
Secondary
| Measure | Time frame |
|---|---|
| A secondary goal of phase 1a (online survey) is to identify a population-based “high” and “low” risk cohort with regard to the likelihood of developing PD and/or dementia using known algorithms (risk assessment). A secondary goal of phase 1b (smell assessment) is to identify eligible subjects for in-person visits of phase 2 according to their olfactory function. A secondary goal of phase 2 (in-person visits) is the clinical and diagnostic characterization of the population-based “high” and “low-risk cohort” as well as the establishment of a longitudinal cohort. | — |
Countries
Austria, Germany, Luxembourg, Spain
Outcome results
None listed