F06.7 F00.0
Conditions
Interventions
Group 1: Subjects with mild cognitive impairment (MCI)
- Standardized counseling and risk disclosure about predictive biomarker-based AD diagnosis
- Quantitative and qualitative measurements with que
Sponsors
Cologne Center for Ethics, Rights, Economics and Social Sciences of Health (ceres),Universität zu Köln
Eligibility
Sex/Gender
All
Age
55 Years to No maximum
Inclusion criteria
Inclusion criteria: For both study arms: •Clinical criteria for late amnestic mild cognitive impairment due to Alzheimers Disease (according to criteria of National Institute on Aging–Alzheimer's Association ): -Performance of 1.5 Standard deviation below the normative mean in one memory test -Single or multiple domain impairment -Cognitive concern reflecting a change in cognition reported by patient or informant or clinician -Preservation of independence in functional abilities •Written informed consent from patient prior to any study procedures. All patients must be able to give informed consent personally and have capacity for such consent. •Patients must have a reliable close other, who is in close contact with the patient and able to contribute to the questionnaires and rating scales at the study visits. This person must sign a separate informed consent form which describes their contributions during the study. •Patients must have fluency in the test language. •Age = 55 years
Exclusion criteria
Exclusion criteria: For both study arms: •Dementia •Evidence of non-Alzheimer's neurodegenerative disorder: parkinson's disease, dementia with Lewy bodies, frontotemporal lobar degeneration, very rapid cognitive decline that occurs over weeks or months (typically indicative of prion disease, neoplasm, or metabolic disorders) •Brain tumor •Presence of extensive cerebrovascular disease on structural brain images, which is suggestive of vascular cognitive impairment •Clinical relevant depressive symptoms (geriatric Depression scale >11), clinical relevant anxiety symptoms (geriatric anxiety inventory >11) and suicidality • Absent caregiver/informant •Illiteracy •Contraindication for lumbar puncture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the expectations with regard to predictive diagnosis of AD in subjects with MCI and their close others (e.g. spouse, partner, children). - The study has 4 survey time points and und 2 Intervention time points: 1) Screening 2) Intervention A: Counseling about the biomarker based AD diagnosis 2) Baseline visit 3) Intervention B: Risk disclosure about the individual risk of developing AD 4) Visit 1 (1 week after risk disclosure) 5) Visit 2 (3 months after risk disclosure) Administration of the following questionnaires: - Mini-Mental State Examination - MMSE - Geriatric Depression Scale – GDS - Geriatric Anxiety Inventory – GAI - Structured Clinical Interview - SCID-I - Resources Utility Questionnaire LITE – RUD - Functional Activities Questionnaire – FAQ - Columbia- Suicide Severity Rating Scale - C-SSRS - Positive and Negative Affect Schedule – PANAS - Flex-Ten Scale short version - Subjective Numeracy Scale - Satisfaction with Life Scale – SWLS - Fragen zur Lebenszufriedenheit – FLZM - WHOQoL Bref - Questionnaire about the personal risk belief - Questionnaire about the personal risk recall - Questionnaire about lifestyle - Questionnaire about spirituality - Questionnaire about the expectations towards the predictive AD diagnosis Furthermore qualitative interviews are performed with the MCI patients and their caregivers. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Assessment of the effects of predictive diagnosis of AD on psychological distress, subjective well-being and quality of life in subjects with MCI and their close others (e.g. spouse, partner, children) -Elaborate an empirically based ethical and legal framework with regard to predicitve diagnosis of Alzheimer's Disease in patients with MCI - Development of a guideline for information and counselling of subjects with MCI and their close others | — |
Countries
Germany, Spain
Contacts
Public ContactCarolin Schwegler
Cologne Center for Ethics, Rights, Economics, and Social Sciences of Health (ceres)
Outcome results
None listed