NCT04245579

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

1.6 years

First QC Date

December 22, 2019

Last Update Submit

January 25, 2020

Conditions

Age-Related Memory Disorders

Keywords

cognitive trainingmemory failuresAPOEbrain volumecognitive reserve

Outcome Measures

Primary Outcomes (16)

  • Change in general cognition

    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.

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

  • Change in verbal memory

    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.

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

  • Change in logical memory

    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.

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

  • Change in visual memory

    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.

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

  • Change in daily memory

    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.

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

  • Change in attentional amplitude

    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.

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

  • Change in attentional control

    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.

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

  • Change in attention and processing speed

    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.

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

  • Change in alternating attention and planning

    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.

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

  • Change in naming ability (language)

    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.

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

  • Change in verbal fluency (language)

    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.

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

  • Change in subjective memory

    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.

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

  • Change in mood

    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.

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

  • The Cognitive Reserve as a predictor of change.

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

    Cognitive Reserve was assessed in the pre-intervention assessment.

  • The Genetic Profile as a predictor of change.

    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).

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

  • The Brain Volume as a predictor of change.

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

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

Study Arms (2)

Experimental Group

EXPERIMENTAL

The experimental group carried out a 30-session multi-factorial group memory training program (UMAM method), with a frequency of three weekly sessions of 90 minutes each. The training program consists of four modules: 1- Stimulation of cognitive processes; learning and practicing internal memory strategies and solving everyday forgetfulness; 2- Instruction in basic concepts about memory; 3- Intervention on daily living and forgetting experiences, using internal and external strategies to solve everyday memory failures; 4- Metacognition or metamemory: the subjects were to reflect about their cognitive failures by analyzing the causes and variables of those failures. In addition, the experimental group followed the standard activities in which all users attending the Center are involved (planned interviews, dialogue-conferences, general health recommendations, etc.).

Other: Multifactorial Memory Training Program (UMAM method)

Control Group

NO INTERVENTION

The Control Group followed the standard activities in which all users attending the Center are involved (planned interviews, dialogue-conferences, general health recommendations, etc.).

Interventions

Multifactorial Memory Training Program (UMAM method)OTHER
Experimental Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Prevención del Deterioro Cognitivo

Madrid, 28006, Spain

Location

Related Publications (1)

  • Montejo Carrasco P, Montenegro-Pena M, Prada Crespo D, Rodriguez Rojo I, Barabash Bustelo A, Montejo Rubio B, Marcos Dolado A, Maestu Unturbe F, Delgado Losada ML. APOE genotype, hippocampal volume, and cognitive reserve predict improvement by cognitive training in older adults without dementia: a randomized controlled trial. Cogn Process. 2024 Nov;25(4):673-689. doi: 10.1007/s10339-024-01202-3. Epub 2024 Jun 19.

    PMID: 38896211DERIVED

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2019

First Posted

January 29, 2020

Study Start

October 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

January 29, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)