Playful Multimodal Intervention, Monitoring and Decision Support for Activation of People With Alzheimer's Dementia

NCT04628702 | Completed

• 1 other identifier: FFG-Benefit 875345
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The worldwide prevalence of dementia is increasing. Pharmaceutical therapies, at the best, slow the degenerative process, observable in Alzheimer's disease (AD). Additional approaches are therefore urgently needed to maintain the patient's independence and the abilities to execute activities of daily living to reduce the patient specific, familial and economic burden. Multimodal tablet-based training might be a potential linchpin in this quest. The primary aim of this study therefore is, to examine the efficacy of the tablet-based training program "Multimodal Activation" (MMA) in mild AD patients. In a randomized controlled trial the investigators aim to include 220 mild AD patients, of which 110 are randomly assigned to the training group receiving guided tablet-based training for 1.5 years, and 110 to the control group. The multimodal intervention, as implemented in the training, includes physical, cognitive and social components. Efficacy of the training will be determined by means of between group pre-post comparison in quantitative neuropsychological and qualitative tests, MRI biomarker and blood biomarker.

Conditions

Alzheimer Disease

Keywords

Alzheimer's disease; tablet-based multimodal training; longitudinal; efficacy

Outcome Measures

Primary Outcomes (3)

• Change of cognition (persons with dementia)

  The "Montreal Cognitive Assessment" has 30 items in 8 domains of cognitive functioning: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. 0-30 points can be obtained. Lower scores indicate a higher degree of cognitive impairment.

  day 0, month 6, month 12, month 18

• Neuropsychological Test Battery

  Pre-post comparisons in cognitive assessment's composite scores will used for efficacy of the tablet-training. The following z-transformed scores will be used to calculate a composite score: Wechsler Memory Scale (WMS-III-R) : Visuelle Paarerkennung I (min-ma:0-18, higher= better) Wechsler Memory Scale (WMS-III-R) : Verbale Paarerkennung I (min-ma:0-24, higher=better) Wechsler Memory Scale (WMS-III-R) : digit span (min-max: Trail Making Test, Version A (min-max: 0-180 seconds, lower better) Trail Making Test, Version B (min-max: 0-300 seconds, lower better) Verbaler Lern- und Merkfähigkeitstest, Subscore "Lernen und Datenakquisition" (min-ma:0-75, higher better) Testbatterie zur Aufmerksamkeitsprüfung (min-ma:0-n.a., lower better) Regensburger Wortflüssigkeitstest (verbal fluency test; 0-max, higher better); Letter Digit Subsitution Test (90 sec)

  day 0, month 18

• Change of cognition (persons with dementia)

  The Mini Mental Status Examination" (MMSE)

  day 0, month 6, month 12, month 18

Secondary Outcomes (12)

• Change of depression (persons with dementia)

  day 0, month 18

• Change of mobility (persons with dementia)

  day 0, month 18

• Change of motivation (persons with dementia)

  day 0, month 18 (AES self); day 0, month 6, month 12, month 18 (AES proxy, FAM)

• Change of quality of life (persons with dementia)

  day 0, month 18

• Change of lifestyle factors (persons with dementia)

  day 0, month 6, month 12, month 18

Study Arms (2)

Intervention group

EXPERIMENTAL

receives tablet-training

Behavioral: tablet training

Control group

NO INTERVENTION

no training

Interventions

tablet training BEHAVIORAL

1.5 year training period

Intervention group

Eligibility Criteria

• Age: 50 Years - 101 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons with dementia
• are diagnosed of possible or probable dementia according to NINCDS-ADRDA criteria (McKhann et al. 2011).
• are older than 40 years at baseline examination.
• are able to speak and understand German and possesses sufficient physical, auditory and visual faculties to take part in a neuropsychological examination and a tablet-based training.
• have been receiving stable medication therapy for a minimum of 3 months before the baseline examination.
• who have been treated with a Memantine therapy, which started 3 months before the baseline examination.
• will be accompanied to the neurological examinations at T0a and T3a at the University Clinic of Neurology by an informal caregiver (relative or other significant person).
• may receive professional 24-hours-care - in this case an informal caregiver must be recruited as participant/accompanying person.
• live at home, with or without an informal caregiver (if alone, an informal caregiver should live nearby).
• receive professional care (e.g. home care services) or informal care (e.g. relatives) or no care yet.
• are willing and able to give informed consent or an informal caregiver with power of representation or a trustee gives the informed consent to participation in the study.
• do not receive any antipsychotic or antidepressive medication or have been stably adjusted to the medication for a minimum of 14 days before study start.
• Informal caregivers
• are significant persons (e.g. family members, friends) of the participating persons with dementia (adults) which provide or do not provide care.
• living or not living with the person with dementia in the same household.

You may not qualify if:

• Participation in a clinical trial until the last three months before study entry
• The participant presumably cannot finish the study
• Any of the following signs in brain MRI:
• Infarct close to major vessels
• More than one lacunar infarction (diameter 1.5cm in every spatial direction)
• One lacunar infarct in a strategic region, such as the thalamus, the hippocampus or the caudate nucleus
• Confluent lesions in deep white matter (Fazekas Score 3)
• Other focal lesions potentially causing cognitive status (e.g. infections, lesions, normal pressure hydrocephalus)
• A general anesthetic three months before study entry or during study period
• The participant has a immunomodulating treatment or will receive a immunomodulating treatment during study period
• Cancer (last treatment \>=5 years before study entry)
• Myocard infarction within 2 years before study entry
• Hepatitis B, C, HIV, Syphilis
• The patient has an active contagious disease
• The patient has a systemic disease potentially causing rapid progression

Sponsors & Collaborators

• Medical University of Graz: lead
• Joanneum Research Forschungsgesellschaft mbH: collaborator
• AustriaN Red Cross (OeRK): collaborator
• health system intelligence (HS & I): collaborator

Study Sites (1)

Medical University of Graz, Austria

Graz, Styria, 8036, Austria

Location

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MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Marisa Koini

  Medical University of Graz, Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Neurologist and neuropsychologist are not informed about intervention
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two groups: interventional group with 1.5 years tablet training and a control group; both groups receive pre-post neurological, neuropsychological examination, MRI and blood sampling at study inclusion and 1.5 years later.

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 13, 2020
• Study Start: February 18, 2020
• Primary Completion: July 1, 2022
• Study Completion: January 31, 2023
• Last Updated: July 5, 2024

Record last verified: 2024-07

Locations

AU (1)