NCT02247180

Brief Summary

This study aims to proof the efficacy of a cognitive rehabilitation program for patients with mild dementia in Alzheimers Disease with respect to activities of daily living.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 23, 2014

Status Verified

September 1, 2014

Enrollment Period

8 months

First QC Date

September 16, 2014

Last Update Submit

September 18, 2014

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in activities of daily living measured by a test for action regulation and planning skills (HOTAP) to the end of intervention and to follow-up (6 months later)

    prior intervention, after intervention (3 months), after 6 months

  • Change from baseline in activities of daily living measured by an ADL-scale (Bayer-ADL) to the end of intervention and to follow-up (6 months later)

    prior intervention, after intervention (3 months), after 6 months

  • Change from baseline in behavioural memory abilities measured by a behavioural memory test (RBMT) to the end of intervention and to follow-up (6 months later)

    prior intervention, after intervention (3 months), after 6 months

Secondary Outcomes (3)

  • Change from baseline in general cognitive state measured by the Consortium to Establish a Registry for Alzheimer´s Disease (CERAD) to the end of intervention and to follow-up (6 months later)

    prior intervention, after intervention (3 months), after 6 months

  • Change from baseline in structural and functional connectivity of the brain measured by MRI to the end of intervention and to follow-up (6 months later)

    prior intervention, after intervention (3 months), after 6 months

  • Change from baseline in depression and quality of life measured by two scales (GDS, DEMQoL) to the end of intervention and to follow-up (6 months later)

    prior intervention, after intervention (3 months), after 6 months

Study Arms (2)

Cognitive Rehabilitation

EXPERIMENTAL

cognitive rehabilitation for 12 weeks

Behavioral: cognitive rehabilitation

Cognitive Training

ACTIVE COMPARATOR

standardized cognitive training in the domesticity

Behavioral: standardized cognitive training

Interventions

cognitive rehabilitationBEHAVIORAL
Cognitive Rehabilitation
standardized cognitive trainingBEHAVIORAL
Cognitive Training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • mild dementia in Alzheimer's disease (NINCDS-ADRDA)
  • Mini Mental State ≥ 17

You may not qualify if:

  • severe psychiatric disorder
  • severe brain disorder (epilepsy, tumor, stroke)
  • contraindication for MRI examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychosomatic Medicine, University of Rostock

Rostock, 18147, Germany

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Stefan Teipel, Prof.

    Department of Psychosomatic Medicine, University of Rostock, Rostock, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabeth Kasper

CONTACT

+49 0381 4949618elisabeth.kasper@med.uni-rostock.de

Yvonne Schmidt

CONTACT

+49 0381 4949471yvonne.schmidt@dzne.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dipl. psych

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 23, 2014

Study Start

September 1, 2014

Primary Completion

May 1, 2015

Study Completion

December 1, 2015

Last Updated

September 23, 2014

Record last verified: 2014-09

Locations

DE(1)