Effects of a Complex Cognitive Training in Mild Cognitive Impairment and Mild Alzheimer's Disease
Primary Purpose
Alzheimer's Disease, Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
complex cognitive training
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring mild Alzheimer's disease, mild cognitive impairment
Eligibility Criteria
Inclusion Criteria:
- Male or female patients aged ≥ 55 years, fulfilling criteria of the National Institute of Neurological and Communicative Disease and Stroke (NINCDS) and the Alzheimer's Disease and Related Disorders Association (ADRDA) for the diagnosis of clinically probable AD or Petersen's criteria of mild cognitive impairment (MCI)
- No evidence for other psychiatric axis I disorders according to DSM-IV criteria
- No uncontrolled arterial hypertension or diabetes mellitus
- No history of drug/alcohol abuse
- Cholinesterase inhibitors or Memantine must have been in a stabile doses at least 2 moths in AD subject group prior to the Baseline
- The patient is able to provide written informed consent to participate in the study. If, at investigator's discretion, a patient is considered not to be capable to give legal consent, then written consent must also be obtained from the patient's legally acceptable representative.
Exclusion Criteria:
- Evidence for other psychiatric axis I disorders according to DSM-IV criteria
- Uncontrolled arterial hypertension or diabetes mellitus
- History of drug/alcohol abuse
- No ability to participate and no willing to give informed consent and comply with the study restrictions
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
cognitive intervention
Outcomes
Primary Outcome Measures
cognition: MMSE, ADAS-cog.
Secondary Outcome Measures
quality of life
Full Information
NCT ID
NCT00544856
First Posted
October 12, 2007
Last Updated
January 28, 2009
Sponsor
Ludwig-Maximilians - University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT00544856
Brief Title
Effects of a Complex Cognitive Training in Mild Cognitive Impairment and Mild Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ludwig-Maximilians - University of Munich
4. Oversight
5. Study Description
Brief Summary
A recent meta-analysis that included over 29.000 individuals found that the odds ratio (OR) of individuals with high brain reserve compared to low was 0.54 (p < 0.0001), a risk decrease of 46%. Among the factors that influence cognitive reserve, mentally stimulating activities was the most robust factor after controlling for education, age, occupation and other potential confounds. The brain reserve effect was sustained over a median longitudinal follow-up of 7 years. It would be interesting to detect whether a complex cognitive training could show similar effects on the cognitive abilities of patients with mild Alzheimer's disease (AD) and mild cognitive impairment (MCI) as it has been reported in previous studies based on mentally stimulating activities analysis.
The hypothesis is that a complex cognitive training alters the neural networks in both subject groups and this alteration is associated with improvement or stabilization of cognitive and non-cognitive function.
The investigator will perform a complex cognitive training program. Twenty patients with mild AD and twenty four patients with MCI will be recruited in this study. The patients will be randomised in control- and treatment groups.Additionally indirect effects on non-cognitive functions will be evaluated in caregivers of the patients.
The investigators expect that the cognitive and non-cognitive abilities will be changed during the cognitive training. The investigators also expect differences between treatment and control groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Cognitive Impairment
Keywords
mild Alzheimer's disease, mild cognitive impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
39 (false)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
cognitive intervention
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
complex cognitive training
Primary Outcome Measure Information:
Title
cognition: MMSE, ADAS-cog.
Time Frame
month 0, 6, 12
Secondary Outcome Measure Information:
Title
quality of life
Time Frame
month 0, 6, 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
95 Years
Eligibility Criteria
Inclusion Criteria:
Male or female patients aged ≥ 55 years, fulfilling criteria of the National Institute of Neurological and Communicative Disease and Stroke (NINCDS) and the Alzheimer's Disease and Related Disorders Association (ADRDA) for the diagnosis of clinically probable AD or Petersen's criteria of mild cognitive impairment (MCI)
No evidence for other psychiatric axis I disorders according to DSM-IV criteria
No uncontrolled arterial hypertension or diabetes mellitus
No history of drug/alcohol abuse
Cholinesterase inhibitors or Memantine must have been in a stabile doses at least 2 moths in AD subject group prior to the Baseline
The patient is able to provide written informed consent to participate in the study. If, at investigator's discretion, a patient is considered not to be capable to give legal consent, then written consent must also be obtained from the patient's legally acceptable representative.
Exclusion Criteria:
Evidence for other psychiatric axis I disorders according to DSM-IV criteria
Uncontrolled arterial hypertension or diabetes mellitus
History of drug/alcohol abuse
No ability to participate and no willing to give informed consent and comply with the study restrictions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harald Hampel, MD
Organizational Affiliation
Department of Psychiatry, Ludwig-Maximilian University, Munich Germany
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
23290333
Citation
Buschert VC, Giegling I, Teipel SJ, Jolk S, Hampel H, Rujescu D, Buerger K. Long-term observation of a multicomponent cognitive intervention in mild cognitive impairment. J Clin Psychiatry. 2012 Dec;73(12):e1492-8. doi: 10.4088/JCP.11m07270.
Results Reference
derived
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Effects of a Complex Cognitive Training in Mild Cognitive Impairment and Mild Alzheimer's Disease
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