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

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

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.

Study Overview

• Status: Completed
• Conditions: Age-Related Memory Disorders
• Intervention / Treatment: Other: Multifactorial Memory Training Program (UMAM method)

• Study Type: Interventional
• Enrollment (Actual): 199
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28006
    • Centro de Prevención del Deterioro Cognitivo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 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)
No Intervention: Control Group; The Control Group followed the standard activities in which all users attending the Center are involved (planned interviews, dialogue-conferences, general health recommendations, etc.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Madrid Salud
• Collaborators: Universidad Complutense de Madrid; Hospital San Carlos, Madrid; Centro de Tecnología Biomédica, Madrid

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: December 22, 2019
• First Submitted That Met QC Criteria: January 25, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 25, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: APOE; cognitive training; memory failures; brain volume; cognitive reserve
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Dementia; Memory Disorders
• Other Study ID Numbers: 15/382-E_BS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No