Cognitive Behavioural Therapy of Early Dementia | NCT00735046

Studies
Cognitive Behavioural Therapy of Early Dementia

NCT00735046

Sponsor

Technical University of Munich

Status

Completed

Last Update Posted

Jan 14, 2011Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Dementia

Interventions

Cognitive behavioral therapy for early Alzheimer's disease
Control

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Not provided

Completion Date

Apr 2010Actual

First Submitted Date

Aug 13, 2008

First Submission Date that Met QC Criteria

Aug 13, 2008

First Posted Date

Aug 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2011

Last Update Posted Date

Jan 14, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Technical University of MunichOTHER

Collaborators

Name	Class
University of Leipzig	OTHER
Zentralinstitut für Seelische Gesundheit Mannheim	OTHER
Humboldt-Universität zu Berlin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

The KORDIAL study is a randomized, controlled, parallel-group trial evaluating the efficacy of a cognitive behavioral therapy for patients at the early stage of Alzheimer's disease. The 3-month experimental intervention consists of 12 individual sessions with regular involvement of carers or other patient proxies. Strategies for improving the patient's coping ability and for enhancing their psychological well-being are combined. The primary outcome criterion is functioning in the everyday context after completion of the intervention and after another 6 months. The control condition will be treatment as usual. The study will be conducted in 5 university outpatient units and in 5 specialist offices.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Intervention	Behavioral: Cognitive behavioral therapy for early Alzheimer's disease
2		control	Other: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive behavioral therapy for early Alzheimer's disease	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional ability in the everyday context		Baseline, post treatment, 6 months post treatment

Secondary Outcomes

Measure	Description	Time Frame
Quality of life, depression, neuro-psychiatric symptoms		Same as for primary outcome

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexander Kurz, MD	Klinikum rechts der Isar	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prof. Dr. A. Kurz, Department of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Technische Universitaet Muenchen		Munich	Bavaria	81675	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15380875	Background	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.
16228161	Background	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.

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D019965	Neurocognitive Disorders

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities