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Completed

NCT Number: NCT04245579

Effectiveness of a Cognitive Training Program (UMAM Method) in Elderly People Without Dementia

The study is oriented to analyze the effectiveness of a cognitive training method (UMAM) on cognitive functions, subjective memory and mood state in elderly people without dementia. On the other hand, the study aims to examine whether variables such as cognitive reserve (e.g. educational level), APOE genotype and intracranial volume are related to increased benefit after the intervention. The researchers hope to find that greater cognitive reserve, not having the APOE allele ε4, and a greater volume of memory-related brain areas, are associated with better outcomes after the cognitive intervention.

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Key information

Conditions

Age-related Memory Disorders Memory Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Prevención del Deterioro Cognitivo

Madrid, 28006, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being over 60 years old.
  • Having a global cognitive performance > 23 in the Mini Mental State Examination Test.
  • Having no history of neurological or serious psychiatric disorders (severe psycho-affective disorders and psychosis or other psychiatric disorders like alcoholism).

Exclusion criteria

  • Chronic use of anxiolytics.
  • Chronic use of neuroleptics.
  • Chronic use of anticonvulsants.
  • Having hearing or vision impairments that would preclude testing.
  • Magnetic Resonance Imaging (MRI) contraindications.

Treatment and study plan

Multifactorial Memory Training Program (UMAM method)

Other

Primary outcomes

  1. Change in general cognition

    Time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.

    The measure of the post-intervention change in general cognition, assessed with the Mini Mental State Examination Test (MMSE) and the 7 Minutes Test (7M).The score ranges from 0 to 30 points (MMSE) and from 0 to 89 points (7M). In both cases, the higher scores indicate a better outcome.

  2. Change in verbal memory

    Time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.

    The measure of the post-intervention change in verbal memory, assessed with the Word List Test of the Wechsler Memory Scale-III. The score ranges from 0 to 48 points. Higher scores indicate a better outcome.

  3. Change in logical memory

    Time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.

    The measure of the post-intervention change in immediate and delayed logical memory, assessed with the Logical Memory Test (immediate and delayed units) of the Wechsler Memory Scale-III. The score ranges from 0 to 75 points (immediate units) and from 0 to 50 (delayed units). Higher scores indicate a better outcome.

  4. Change in visual memory

    Time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.

    The measure of the post-intervention change in visual memory, assessed with the Rey memory test (form B). The score ranges from 0 to 22 points. Higher scores indicate a better outcome.

  5. Change in daily memory

    Time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.

    The measure of the post-intervention change in daily memory, assessed with the Rivermead Behavioral Memory Test. The score ranges from 0 to 24 points. Higher scores indicate a better outcome.

  6. Change in attentional amplitude

    Time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.

    The measure of the post-intervention change in attentional amplitude, assessed with the Direct Digit Test of the Wechsler Memory Scale-III. The score ranges from 0 to 16 points. Higher scores indicate a better outcome.

  7. Change in attentional control

    Time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.

    The measure of the post-intervention change in attentional control, assessed with the Inverse Digit Test of the Wechsler Memory Scale-III. The score ranges from 0 to 14 points. Higher scores indicate a better outcome.

  8. Change in attention and processing speed

    Time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.

    The measure of the post-intervention change in attention, assessed with the Trail Making Test, form A. The score ranges from 0 to 200 points. Higher scores indicate a worse outcome.

  9. Change in alternating attention and planning

    Time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.

    The measure of the post-intervention change in alternating attention and planning, assessed with the Trail Making Test, form B. The score ranges from 0 to 400 points. Higher scores indicate a worse outcome.

  10. Change in naming ability (language)

    Time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.

    The measure of the post-intervention change in naming ability, assessed with the Boston Naming Test. The score ranges from 0 to 60 points. Higher scores indicate a better outcome.

  11. Change in verbal fluency (language)

    Time frame: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.

    The measure of the post-intervention change in phonologic and semantic verbal fluency, assessed with the Phonological Verbal Fluency Test and the Semantic Fluency Test respectively. The score goes from zero onwards (there is no upper limit). Higher scores indicate a better outcome.

  12. Change in subjective memory

    Time frame: This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.

    The measure of the post-intervention change in Subjective Memory, assessed with the Memory Failures of Everyday Questionnaire.The score ranges from 0 to 56 points. Higher scores indicate a worse outcome.

  13. Change in mood

    Time frame: This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.

    The measure of the post-intervention change in mood, assessed with the Geriatric Depression Scale. The score ranges from 0 to 15 points. Higher scores indicate a worse outcome.

  14. The Cognitive Reserve as a predictor of change.

    Time frame: Cognitive Reserve was assessed in the pre-intervention assessment.

    The Cognitive Reserve was assessed with Rami Test. The score ranges from 0 to 25 points.

  15. The Genetic Profile as a predictor of change.

    Time frame: The Genetic Profile was assessed in the pre-intervention assessment.

    The Genetic Profile was obtained by genetic analysis employing a blood test. APOE gene has been coded as 1 (meaning no ε4 allele), or 0 (for at least one ε4 allele).

  16. The Brain Volume as a predictor of change.

    Time frame: The Brain Volume was assessed in the pre-intervention assessment.

    The Brain Volume (total gray volume, left hippocampus, right hippocampus and total intracranial volume) was assessed by magnetic resonance imaging. Unit of measure: mm3.

Sponsors and collaborators

Lead sponsor

Madrid Salud

Other

Collaborators

  • Centro de Tecnología Biomédica, Madrid
  • Hospital San Carlos, Madrid
  • Universidad Complutense de Madrid

Registry information

Official study title

Cognitive Training in Elders Without Dementia Using UMAM Method. Genetic, Brain Volume and Cognitive Reserve Predictors: A Randomized Controlled Study

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 29, 2020
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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