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Effects of a Complex Cognitive Training in Mild Cognitive Impairment and Mild Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00544856
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : January 29, 2009
Information provided by:
Ludwig-Maximilians - University of Munich

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Cognitive Impairment Behavioral: complex cognitive training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : October 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
cognitive intervention
Behavioral: complex cognitive training
Placebo Comparator: 2 Behavioral: complex cognitive training

Primary Outcome Measures :
  1. cognition: MMSE, ADAS-cog. [ Time Frame: month 0, 6, 12 ]

Secondary Outcome Measures :
  1. quality of life [ Time Frame: month 0, 6, 12 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   55 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00544856

Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
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Study Chair: Harald Hampel, MD Department of Psychiatry, Ludwig-Maximilian University, Munich Germany
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00544856    
Other Study ID Numbers: cogT001
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: January 29, 2009
Last Verified: January 2009
Keywords provided by Ludwig-Maximilians - University of Munich:
mild Alzheimer's disease
mild cognitive impairment
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders