Trial document




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  DRKS00010864

Trial Description

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Title

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

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Trial Acronym

Train-ParC-D

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URL of the Trial

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Brief Summary in Lay Language

Besides the movement disorders which are of high relevance for the diagnosis, also non-motor symptoms, e.g. cognitive dysfunctions, can occur in Parkinson's disease. These symptoms are very burdening for the patients and their relatives. Patients with Parkinson's disease have a three to five times higher risk of developing dementia in the course of the disease.

Next to pharmacological treatment, non-pharmacological interventions are more and more in the clinical and scientific focus. These interventions comprise e.g. cognitive therapies and physical exercises. The positive effects of cognitive interventions in patients with other types of dementia could be demonstrated in several studies.

In this study, we want to examine the effectiveness of cognitive stimulation – a particular form of cognitive therapy – for patients with Parkinson's disease dementia within a randomized controlled trial. An exercise program, which is probably not cognitively stimulating, will be the control intervention in this trial.

Both intervention types are offered in small groups of 3 to 5 persons over a period of 8 weeks, twice a week for 60 minutes. The short-term effects but also possible long-term effects after 3 and 12 months on cognition, quality of life, further behavioral and psychological symptoms, activities of daily living, motor symptoms and caregiver burden as well as quality of life and the depression level of the caregivers will be examined.

For that reason, neuropsychological tests and questionnaires as well as clinical examinations of the motor symptoms will be used. In addition, it will be investigated which sociodemographic, neuropsychological and clinical aspects predict the success of the intervention.

In addition, a health-economic evaluation will be performed. This means that we will investigate whether the benefits to the patients and his/her family members are sufficient enough to justify the time and costs of the cognitive stimulation program. This is especially important because health insurance bodies need such information in order to decide whether the costs for such therapies should be covered in the future.

We aim to include a total of 82 patients from six different hospitals in Germany (Cologne, Düsseldorf, Essen, Bochum, Kiel, and Tübingen) in the study. For the evaluation of the effectiveness of the interventions, it is also intended that the patients’ caregivers, who are involved in the patients’ care, provide information about the patients. Therefore, different questionnaires and interviews to assess different aspects (e.g. mood, activities of daily living (ADL), and psychiatric symptoms) will be used. In addition, we follow the approach that we would like to know not only whether the therapies are effective for the patients, but whether the participation in a group program lasting several weeks may result in positive effects for the relatives as well (e.g. caregiver burden, quality of life).

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Brief Summary in Scientific Language

The efficacy of cognitive training in Parkinson’s disease patients without cognitive impairment, as well as with mild cognitive impairment (MCI) could already be examined in several studies.

However, there is no study that examined the effectiveness of cognition-based interventions, in particular cognitive stimulation in patients with Parkinson’s disease dementia.

Additionally, there is only limited knowledge regarding predictors of training success for cognitive interventions in patients with Parkinson’s disease. Health-economic evaluations are missing entirely.

That is why for the first time the effectiveness of a cognitive stimulation program in patients with Parkinson’s disease dementia on the outcomes cognition, quality of life, depression, further behavioral and psychological symptoms, activities of daily living, motor symptoms and caregiver burden as well as quality of life and depression level of the caregivers will be examined.

Furthermore, we aim to identify possible sociodemographic, neuropsychological and clinical predictors for training success. Finally, a health-economic evaluation for the cognitive stimulation program in patients with Parkinson’s disease dementia will be conducted.

The study project is designed as a multicentre, single-blind, randomized controlled trial. The six centres (Cologne, Düsseldorf, Essen, Bochum, Kiel, and Tübingen) will recruit a total of 82 patients with Parkinson’s disease dementia. Those patients will be randomly assigned to either an experimental group receiving cognitive stimulation twice a week for 60 minutes over 8 weeks, or to an active control group receiving physical exercise in the equivalent amount of time. Before and after the intervention, as well as 3 and 12 months after the end of the 8 week intervention, an elaborated neuropsychological test battery and clinical tests for motor symptoms will be performed with the patients and their relatives. This is the first study which investigates the short-term, medium-term and long-term effects of a cognitive stimulation program in patients with Parkinson’s disease dementia. The cognitive performance is set as the primary outcome. Quality of life, depression, behavioral and psychological symptoms, activities of daily living (ADLs), motor functions as well as caregiver burden, quality of life and depression of the caregivers are set as secondary outcomes. Qualitative interviews with chosen caregivers are conducted to gain further information on individual-related changes of the patients’ who participated in the cognitive stimulation program, as well as on changes in caregiver burden. Further, socio-demographic, neuropsychological and clinical predictors of training success will be analyzed. Finally, a health-economic (cost-efficacy) analysis for the cognitive stimulation program in patients with Parkinson’s disease patients will be conducted.

The following hypotheses will be tested: 1) There are significant positive short-term, medium-term and long-term effects on cognition and quality of life in the experimental group compared to the control group. 2) There are significant positive short-term, medium-term and long-term effects on motor function in the control group compared to the experimental group. 3) Training success can be predicted with the help of sociodemographic (higher age, female gender), neuropsychological (lower cognitive baseline scores) and clinical (less functional constraints, lower level of depression, lower level of apathy) parameters. 4) A cognitive stimulation program for patients with Parkinson’s disease dementia is cost-effective.

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Organizational Data

  •   DRKS00010864
  •   2017/04/19
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  •   yes
  •   Approved
  •   16-297, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   F02.3 -  Dementia in Parkinson disease
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Interventions/Observational Groups

  •   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 time period of 8 weeks. The program takes place in small groups with 3 to 5 participants. Next to cognitive exercises, each session includes training of fine motor skills and multisensory stimulation.
  •   The active control group participates in a physical training with a specific focus on stretching, flexibility, balance, and relaxation, which remains below 50% of the heart rate reserve. Effects on motor symptoms are expected, but no impact on cognitive functions is assumed. The physical training takes place twice a week for 60 minutes over 8 weeks in small groups of 3 to 5 patients – similar to the cognitive stimulation program.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

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).

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Secondary Outcome

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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2017/06/09
  •   82
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   85   Years
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Additional 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.

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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.

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Addresses

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    • Medizinische Psychologie | Neuropsychologie und Gender Studies & Centrum für Neuropsychologische Diagnostik und Intervention (CeNDI)
    • Ms.  Univ.-Prof. Dr.  Elke  Kalbe 
    • Kerpenerstraße 68
    • 50937   Köln
    • Germany
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    • Elisabeth-Krankenhaus Essen Geriatrie-Zentrum Haus Berge
    • Mr.  Prof. Dr.  Richard  Dodel 
    • Germaniastraße 3
    • 45356  Essen
    • Germany
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    • Universitätsklinikum Düsseldorf Institut für Klinische Neurowissenschaften und Medizinische Psychologie
    • Mr.  PD Dr.  Lars  Wojtecki 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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    • Universitätsklinikum Kiel Klinik für Neurologie
    • Ms.  Prof. Dr.  Daniela  Berg 
    • Arnold-Heller-Straße 3
    • 24105  Kiel
    • Germany
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    • Abtl. NeurodegenerationHertie Institut für klinische Hirnforschung und Deutsches Zentrum für Neurodegenerative Erkrankungen
    • Ms.  PD Dr.  Inga  Liepelt-Scarfone 
    • Hoppe-Seyler Str. 3
    • 72076  Tübingen
    • Germany
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    • Neurologische Klinik der Ruhr-Universität Bochum, St. Josef-Hospital
    • Mr.  Prof. Dr.  Siegfried  Muhlack 
    • Gudrunstraße 56
    • 44791  Bochum
    • Germany
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    • Neurologische Klinik der Ruhr-Universität Bochum, St. Josef-Hospital
    • Mr.  Prof. Dr.  Lars  Tönges 
    • Gudrunstr. 56
    • 44791  Bochum
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Medizinische Psychologie | Neuropsychologie und Gender Studies & Centrum für Neuropsychologische Diagnostik und Intervention (CeNDI)
    • Ms.  Univ.-Prof. Dr.   Elke  Kalbe 
    • Kerpenerstraße 68
    • 50937  Köln
    • Germany
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    • Universitätsklinikum Köln, Medizinische Psychologie | Neuropsychologie und Gender Studies &Centrum für Neuropsychologische Diagnostik und Intervention (CeNDI)
    • Ms.  Gerontologin (M.A.)  Ann-Kristin  Folkerts 
    • Kerpenerstraße 68
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Köln Medizinische Psychologie | Neuropsychologie und Gender Studies
    • Ms.  Prof. Dr.  Elke  Kalbe 
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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    • Universitätsklinikum DüsseldorfInstitut für Klinische Neurowissenschaften und Medizinische Psychologie
    • Mr.  Dr.  Lars  Wojtecki 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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    • Elisabeth-Krankenhaus EssenGeriatrie-Zentrum Haus Berge
    • Mr.  Prof. Dr.  Richard  Dodel 
    • Germaniastraße 3
    • 45356  Essen
    • Germany
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    • Universitätsklinikum KielKlinik für Neurologie
    • Ms.  Prof. Dr.  Daniela  Berg 
    • Arnold-Heller-Straße 3
    • 24105  Kiel
    • Germany
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    • Universitätsklinikum Tübingen Hertie Institut für klinische Hirnforschung und Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE)
    • Ms.  Dr.  Inga  Liepelt-Scarfone 
    • Hoppe-Seyer Str. 3
    • 72076  Tübingen
    • Germany
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    • Deutsche Parkinson Gesellschaft e.V.
    • Reinhardtstr. 27 C
    • 10117  Berlin
    • Germany
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    • Neurologische Klinik der Ruhr-Universität BochumSt. Josef Hospital
    • Mr.  Prof. Dr.  Siegfried  Muhlack 
    • Gudrunstraße 56
    • 44791  Bochum
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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