NCT00735046

Brief Summary

A randomized, controlled, parallel-group trial to evaluate the efficacy of a cognitive behavioral therapy for patients with early dementia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

January 14, 2011

Status Verified

July 1, 2008

First QC Date

August 13, 2008

Last Update Submit

January 13, 2011

Conditions

Keywords

Early dementia in Alzheimer's disease (MMSE ≥ 21)

Outcome Measures

Primary Outcomes (1)

  • Functional ability in the everyday context

    Baseline, post treatment, 6 months post treatment

Secondary Outcomes (1)

  • Quality of life, depression, neuro-psychiatric symptoms

    Same as for primary outcome

Study Arms (2)

1

Intervention

Behavioral: Cognitive behavioral therapy for early Alzheimer's disease

2

control

Other: Control

Interventions

12 weekly individual sessions, total duration 3 months, regular involvement of patient's proxy ever second session. Intervention is manualized but is flexible with regard to individual resources and needs.

1
ControlOTHER

Patients and proxies who are assigned to treatment as usual

2

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to memory clinics and specialist (psychiatrist, neurologist) offices

You may qualify if:

  • Mild dementia (MMSE \> 21) in Alzheimer's disease (ICD-10), proxy available

You may not qualify if:

  • Acute of unstable psychiatric or physical disease, proxy unavailable
  • Participation in another trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. A. Kurz, Department of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Technische Universitaet Muenchen

Munich, Bavaria, 81675, Germany

Location

Related Publications (3)

  • Kliegel M, Eschen A, Thone-Otto AI. Planning and realization of complex intentions in traumatic brain injury and normal aging. Brain Cogn. 2004 Oct;56(1):43-54. doi: 10.1016/j.bandc.2004.05.005.

    PMID: 15380875BACKGROUND
  • Werheid K, Thone-Otto AI. [Cognitive training in Alzheimer's dementia]. Nervenarzt. 2006 May;77(5):549-57. doi: 10.1007/s00115-005-1998-2. German.

    PMID: 16228161BACKGROUND
  • Kurz A, Pohl C, Ramsenthaler M, Sorg C. Cognitive rehabilitation in patients with mild cognitive impairment. Int J Geriatr Psychiatry. 2009 Feb;24(2):163-8. doi: 10.1002/gps.2086.

    PMID: 18636436BACKGROUND

Biospecimen

Retention: NONE RETAINED

not required

MeSH Terms

Conditions

Dementia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Alexander Kurz, MD

    Klinikum rechts der Isar

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 14, 2008

Study Start

April 1, 2008

Study Completion

April 1, 2010

Last Updated

January 14, 2011

Record last verified: 2008-07

Locations