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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
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

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

55 Years - 95 Years (Adult, Older Adult)All Sexes

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

    First Posted
    October 12, 2007
    Last Updated
    January 28, 2009
    Sponsor
    Ludwig-Maximilians - University of Munich
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    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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