MedPath

Assistant to activate patients with dementia and their caregivers

Phase 2
Conditions
F00
F01
Dementia in Alzheimer disease
Vascular dementia
Registration Number
DRKS00013638
Lead Sponsor
Ambulante Diakonische Dienste gGmbH
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
53
Inclusion Criteria

1) type of dementia: Alzheimer’s disease or vascular dementia; diagnosed by professionals in memory clinic (CERAD neuropsychological battery); alternative for Siegen: Clinical Dementia Rating (CDR; Morris, 1993) value > 0.5
2) give consent
3) participants are retired
4) participants are mobile and able to stand up from a chair without support and walk 6m
5) care dependency measured by barthel index (BI): criteria: BI< 60 points (Mahoney & Barthel, 1965)
6) support by a professional caregiver or by an informal caregiver
7) written informed consent from patient with dementia and the informal caregiver
8) medical certification
9) cognitive and social requirements (interested, motivated, no aggressive behavior, can imitate exercises, understand simple verbal information, control of emotional reactions)
10) physical requirements (routine actions can be completed; also he/she can: see, hear, speak, sit and stand up, walk, grab and hold on a chair)
11) conditions of the environments (TV with HDMI, wireless internet at home)

Exclusion Criteria

1) other types of dementia (frontotemporal dementia, dementia with Lewy bodies, alcohol-relates brain damage (Korsakoff´s syndrome), familial Alzheimer's disease)
2) mental disorders like depression or generalized anxiety disorder who have not been satisfactorily medicated for at least six months; substance-related disorders in the last 2 years; schizophrenia and other psychological disorders
3) neurodegenerative diseases of the Central Nervous System (CNS), Parkinson’s disease, multiple sclerosis, Amyotrophic Lateral Sclerosis (ALS)
4) cardiovascular diseases: acute cardiac failure, acute cardiac insufficiency, angina pectoris, untreated cardiac arrhythmia or heart valve disease, pacemaker, untreated hypertension - systolic blood pressure >180 mm Hg or diastolic blood pressure > 110 mm Hg; untreated hypotension - < 90/60 mm Hg
5) untreated cancer disease
6) untreated hormone diseases
7) badly controlled diabetes (blood glucose < 6 mmol/L or >15 mmol/L)
8) epilepsy
9) Chronic Obstructive Pulmonary Disease (COPD) grade 4
10) acute infection or fever
11) acute renal insufficiency
12) osteoporosis
13) surgical interventions in the last 6 months
14) taking neuroleptics or benzodiazepine
15) participation in another study for dementia

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath