Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00544856
First received: October 12, 2007
Last updated: January 28, 2009
Last verified: January 2009
History of Changes
  Purpose

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 Intervention
Alzheimer's Disease
Cognitive Impairment
 Behavioral: complex cognitive training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • cognition: MMSE, ADAS-cog. [ Time Frame: month 0, 6, 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: month 0, 6, 12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 39
Study Start Date: October 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
cognitive intervention
 Behavioral: complex cognitive training
Placebo Comparator: 2 Behavioral: complex cognitive training

  Eligibility

Ages Eligible for Study:   55 Years to 95 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00544856

Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Study Chair: Harald Hampel, MD Department of Psychiatry, Ludwig-Maximilian University, Munich Germany
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00544856     History of Changes
Other Study ID Numbers: cogT001
Study First Received: October 12, 2007
Last Updated: January 28, 2009
Health Authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection

Keywords provided by Ludwig-Maximilians - University of Munich:
mild Alzheimer's disease
mild cognitive impairment

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 17, 2012