F02.3
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Diagnosis of idiopathic Parkinson's disease (confirmed by a neurologist or psychiatrist); - Parkinson's disease dementia according to Level-I-Diagnosis of the Movement Disorder Society Task Force (Dubois et al., 2007; Emre et al., 2007); - Mild to moderate dementia operationalized with the help of the MMSE (range: 25 to 10 points); - The patient is able to follow instructions; - The patient is able to walk at least 10 meters without any help; - Age: 50 to 85 years; - German as native language or excellent German speaking skills; - No/corrected visual or auditory impairments; - Informed consent of a relative of the patient to complete external ratings of the patient as well as self-ratings.
Exclusion criteria
Exclusion criteria: - MMSE score above 25 points or below 10 points; - Major depression (operationalized with the GDS > 10 points); - Acute suicidality; - Alcohol or drug abuse in the last three years; - Severe neurological and/or psychiatric diseases with cognitive symptoms (acute or in the past; psychosis, epilepsy, stroke, traumatic brain injury, brain tumor); - Further severe/life-threatening comorbidities which constitute an obstacle to the participation in a study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognition; time points of measurement: pre- and posttest and follow-up after 3 and 12 months; instruments used: CERAD-PLUS; digits backwards (Wechsler Memory Scale). | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient related outcomes: Quality of life; instrument used: Quality of Life in Alzheimer's Disease (QoL-AD; self-rating); Depression; instruments used: Geriatric Depression Scale (GDS; self-rating); Cornell Depression Scale (CDS; external rating); Behavior and psychological symptoms; instrument used: Neuropsychiatric Inventory (NPI; external rating); Activities of daily living (ADL); instrument used: Bayer ADL-Scale (B-ADL; external rating); Motor function; instruments used: Unified Parkinson Disorder Rating Scale (UPDRS) – Scale III (motor examination); Unified Parkinson Disorder Rating Scale (UPDRS) – Scale V (Hoehn & Yahr Staging, external rating); Timed “Up and Go”-Test (including a cognitive and manual dual-task exercise; TUG); Caregiver related outcomes: Caregiver burden; instrument used: Zarit Burden Interview (ZBI; self-rating); Quality of life; instrument used: EQ-5D-5L (self-rating); Depression; instrument used: Beck's Depression Inventory II (BDI-II; self-rating); All secondary outcomes were assesed at pre- and posttest (short-term effects) as well as at the follow-up after 3 (medium-term effects) and 12 (long-term effects) months. | — |
Countries
Germany, Luxembourg
Contacts
Universitätsklinikum Köln, Medizinische Psychologie | Neuropsychologie und Gender Studies &Centrum für Neuropsychologische Diagnostik und Intervention (CeNDI)