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Cognitive Stimulation in patients with Parkinson's Disease Dementia (Train-ParC-D): Efficacy, prediction of response, and health-economic evaluation.

Cognitive Stimulation in patients with Parkinson's Disease Dementia (Train-ParC-D): Efficacy, prediction of response, and health-economic evaluation. - Train-ParC-D

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00010864
Enrollment
82
Registered
2017-04-19
Start date
2017-06-28
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F02.3

Interventions

Group 1: The intervention program for the experimental group is a structured cognitive stimulation program (“NEUROvitalis SINNreich”) which is offered twice a week (16 sessions) for 60 minutes over a

Sponsors

Medizinische Psychologie | Neuropsychologie und Gender Studies & Centrum für Neuropsychologische Diagnostik und Intervention (CeNDI)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 85 Years

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

MeasureTime 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

MeasureTime 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

Public ContactAnn-Kristin Folkerts

Universitätsklinikum Köln, Medizinische Psychologie | Neuropsychologie und Gender Studies &Centrum für Neuropsychologische Diagnostik und Intervention (CeNDI)

ann-kristin.folkerts@uk-koeln.de+49 221 478-96248?

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026