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Age-related Cognitive DeclineNCT03771131

A Group Study on the Effects of a Short Multi-Domain Cognitive Training in Healthy Elderly Italian People

A study testing Multi-domain cognitive training in people with Age-related Cognitive Decline, run by University of Milano Bicocca at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Alongside physiological cognitive ageing, nowadays there is an alarming increase in the incidence of dementia that requires communities to invest in its prevention. The engagement in cognitively stimulating activities and strong social networks have been identified among those protective factors promoting successful… Read more about this study

Who is it for?
Ages 60 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Age-related Cognitive Decline
What is being tested?
Multi-domain cognitive training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteItaly
Study dates
1 Dec 2013to 1 Jan 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age over 60 years

Who cannot join

  • Negative anamnesis for neurological and/or psychiatric diseases
  • No suspected cognitive impairment as assessed during the pre-training neuropsychological testing (>2 pathological scores)

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • University of Milan-Bicocca

    Milan, 20126

Other trials in Italy

About this study

Alongside physiological cognitive ageing, nowadays there is an alarming increase in the incidence of dementia that requires communities to invest in its prevention. The engagement in cognitively stimulating activities and strong social networks have been identified among those protective factors promoting successful cognitive ageing. One aspect regarding cognitive stimulation concerns the relevance of the frequency of an external intervention. For these reasons, the aim of this study was to evaluate the efficacy of a 3-month multi-domain cognitive training program, administered once per week in a group of healthy elderly aged over 60 years old. Their results obtained on a series of neuropsychological tests, both pre- (t0) and post-training (t1), were compared with those of a passive control group who did not receive the cognitive training.

Read the detailed description

Participants were assigned to the experimental or control group based on their time of application to the program. Both experimental and control group underwent a neuropsychological assessment to investigate different cognitive domains, before and after (~3 months) the training program. Based on the scores obtained during the preliminary neuropsychological assessment, the participants of the experimental training group were divided into small subgroups (ranging from 8 to 12 subjects) to further address individualization of training (i.e. level of difficulty of the exercises proposed). The experimental group attended weekly sessions of the multi-domain cognitive training. Each session lasted around one hour and the overall duration of the training was of 3 months, for a total of 13 sessions. To promote improvement transfer to everyday life, some of the exercises proposed were ecological in their nature, in that, they asked participants to solve tasks that recalled everyday situations (such as remembering names or road maps). Furthermore, throughout the training, approximately once every two sessions brief psycho-educational interventions were provided.

Being tested
Multi-domain cognitive training
Keywords
healthy cognitive ageing, multi-domain cognitive training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-domain cognitive trainingBehavioural

    Weekly sessions of multi-domain cognitive training, each lasting around one hour for an overall duration of the training of 3 months (13 sessions)

Study groups in NCT03771131
Study groupRoleWhat they receive
Experimental groupExperimentalGroup receiving the multi-domain cognitive training
Receives: Behavioral: Multi-domain cognitive training
Control groupNo interventionPassive control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change from pre-training in Montreal Congnitive Assessment (MoCA) scores

    Raw score, assessing global cognitive functioning. Cutoff: < 17.362. Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

    Measured: Pre- and post-training (after ~3 months of training)

  2. Mean change from pre-training in Forward and Backward Digit and Corsi Span scores

    Raw score, assessing verbal and visuo-spatial short term memory. Cutoff: < 4.26 (Forward Digit Span), < 2.65 (Backward Digit Span), < 3.46 (Forward Corsi Span), < 3.08 (Backward Corsi Span). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

    Measured: Pre- and post-training (after ~3 months of training)

  3. Mean change from pre-training in Short Story test scores

    Raw score, assessing verbal long term memory. Cutoff: < 7.5. Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

    Measured: Pre- and post-training (after ~3 months of training)

  4. Mean change from pre-training in Copy and Recall of Rey-Osterrieth Complex Figure scores

    Raw score, assessing constructional abilities and visuo-spatial long term memory. Cutoff: < 28.87 (Copy), < 9.46 (Recall). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

    Measured: Pre- and post-training (after ~3 months of training)

  5. Mean change from pre-training in Semantic and Phonological Verbal Fluency scores

    Raw score, assessing executive functions. Cutoff: < 16 (Phonological), < 24 (Semantic). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

    Measured: Pre- and post-training (after ~3 months of training)

  6. Mean change from pre-training in Stroop color and word test scores

    Raw score, assessing inhibitory control. Cutoff: > 36.92 (for Time measure), > 4.24 (for Error measure). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

    Measured: Pre- and post-training (after ~3 months of training)

  7. Mean change from pre-training in Trail Making test scores

    Raw score, assessing attention. Cutoff: > 93 (TMT A), > 282 (TMT B), > 186 (TMT B-A). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

    Measured: Pre- and post-training (after ~3 months of training)

  8. Mean change from pre-training in Raven's coloured matrices scores

    Raw score, assessing non-verbal reasoning. Cutoff: < 18. Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

    Measured: Pre- and post-training (after ~3 months of training)

Secondary outcomes (1)

  1. Mean scores in the Post-training questionnaire

    Scores assessing both the satisfaction level about the training and the possible impact of the program on participants' everyday activities, mood and socialization. Each question was measured on a 5-point Likert scale (1: most negative score; 5: most positive score).

    Measured: Post-training (after ~3 months of training)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2018
  2. Study start1 Dec 2013
  3. Primary completion1 Jan 2015
  4. Study completion1 Jan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03771131
Sponsor's protocol ID
DD
Status last verified
Dec 2018
First submitted
6 Dec 2018
Last updated
10 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Tagliabue CF, Guzzetti S, Gualco G, Boccolieri G, Boccolieri A, Smith S, Daini R. A group study on the effects of a short multi-domain cognitive training in healthy elderly Italian people. BMC Geriatr. 2018 Dec 27;18(1):321. doi: 10.1186/s12877-018-1014-x.

    PubMed 30587151

Questions about this trial

What is this clinical trial studying?

A study testing Multi-domain cognitive training in people with Age-related Cognitive Decline, run by University of Milano Bicocca at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from pre-training in Montreal Congnitive Assessment (MoCA) scores (time frame: Pre- and post-training (after ~3 months of training)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03771131, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2018.

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