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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Multifactorial Memory Training Program (UMAM method)

About this trial

This is an interventional prevention trial for Age-Related Memory Disorders focused on measuring cognitive training, memory failures, APOE, brain volume, cognitive reserve

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Centro de Prevención del Deterioro Cognitivo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

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.).

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

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

The Cognitive Reserve as a predictor of change.

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

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 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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04245579

First Posted

December 22, 2019

Last Updated

January 25, 2020

Sponsor

Madrid Salud

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04245579

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

October 2013 (Actual)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Madrid Salud

Collaborators

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

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age-Related Memory Disorders

Keywords

cognitive training, memory failures, APOE, brain volume, cognitive reserve

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

199 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Group

Arm Type

Experimental

Arm Description

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.).

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Multifactorial Memory Training Program (UMAM method)

Primary Outcome Measure Information:

Title

Change in general cognition

Description

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.

Time Frame