NCT04353947

Brief Summary

This study evaluates the differences in cognitive function between healthy older adults, older adults with mild Alzheimer's type dementia and older adults with Parkinson's disease and if there are differences in valence assessment and activation that produce them a mood induction task. Subjects are assessed using neuropsychological tests and then a mood induction task based on movie clips is applied.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

8 months

First QC Date

April 16, 2020

Last Update Submit

May 3, 2021

Conditions

Healthy Older AdultsAlzheimer's DiseaseParkinson's Disease

Keywords

Healthy older adultsAlzheimer's diseaseParkinson's diseaseMood inductionPositive emotionsNegative emotions

Outcome Measures

Primary Outcomes (10)

  • Mini-Mental State Examination (MMSE)

    This test is evaluated on a maximum of 30 points. Participants with scores equal to or below 23 would be considered cognitively deficient.

    5-10 minutes

  • Beck Depression Inventory-II (BDI-II)

    In this test, a score of 0-13 indicates absence of depression, 14-19 mild depression, 20-28 moderate depression, and 29-63 severe depression.

    5-10 minutes

  • Global Deterioration Scale (GDS)

    This scale indicates seven possible stages: 1. Absence of Cognitive Deficit; 2. Very slight cognitive deficit; 3. Mild Cognitive Deficit; 4. Moderate cognitive deficit; 5. Moderately severe cognitive deficit; 6. Severe cognitive deficit; 7. Very severe cognitive deficit.

    30 minutes

  • Memory alteration test (M@T)

    This cognitive test is evaluated on a maximum of 50 points. The optimal cut-off point for distinguishing mild cognitive impairment of the amnesiac type from subjective memory complaints is 37 points. The optimal cut-off point for Alzheimer's disease is 31 points.

    5-10 minutes

  • Spanish-Complutense Verbal Learning Test (TAVEC)

    The evaluator reads a 16-word shopping list in five different essays and in each of them the evaluated person must mention those words that he or she remembers. After 20 minutes, the subject is asked to remember them again.

    30 minutes

  • Barcelona test (BT)

    In this test, the subject is considered to have a good categorical evocation when he is able to evoke more than 16 animals in 1 minute and a good verbal fluency when he is able to evoke more than 19 words beginning with "p" in 3 minutes.

    5 minutes

  • Rey-Osterrieth Complex Figure Test (ROCFT)

    The direct score (PD) in the copy of the Rey figure that would leave 50% of the population below is 30 points, while in the reproduction of the Rey figure from memory the PD that would leave 50% below of the population is 21 points.

    10 minutes

  • Frontal assessment battery (FAB)

    The maximum score to be obtained in this test is 18 points. To consider that the subject presents alterations in the frontal lobe and, therefore, altered executive functions, his score must be equal to or less than 11 points.

    10 minutes

  • Positive and Negative Affect Scale (PANAS)

    The final score of this scale is the sum of the 10 terms on the positive scale and the sum of the 10 terms on the negative scale, with the value assigned for the responses on the positive scale being positive and negative for the responses on the negative scale.

    10 minutes

  • Auto-Assessment Manikins (SAM)

    This questionnaire measures the valence (liking/disliking depending on the emotion induced by scenes from different movies), the arousal (excitement caused by each of the movie scenes) and mastery or emotional control (self-perception of the control exerted on the environment and the emotion itself).

    5-10 minutes

Study Arms (3)

Healthy older adults

Healthy older adults with 65 years or older

Diagnostic Test: Mini Cognitive Examination (MCE)Diagnostic Test: Beck Depression Inventory-II (BDI-II)Diagnostic Test: Global Deterioration Scale (GDS)Diagnostic Test: Memory alteration test (M@T)Diagnostic Test: Spanish-Complutense Verbal Learning Test (TAVEC)Diagnostic Test: Barcelona test (BT)Diagnostic Test: Rey-Osterrieth Complex Figure Test (ROCFT)Diagnostic Test: Positive and Negative Affect Scale (PANAS)Diagnostic Test: Auto-Assessment Manikins (SAM)

Older adults with Alzheimer's disease

Older adults with Alzheimer's disease with 65 years or older

Diagnostic Test: Mini Cognitive Examination (MCE)Diagnostic Test: Beck Depression Inventory-II (BDI-II)Diagnostic Test: Global Deterioration Scale (GDS)Diagnostic Test: Memory alteration test (M@T)Diagnostic Test: Spanish-Complutense Verbal Learning Test (TAVEC)Diagnostic Test: Barcelona test (BT)Diagnostic Test: Rey-Osterrieth Complex Figure Test (ROCFT)Diagnostic Test: Positive and Negative Affect Scale (PANAS)Diagnostic Test: Auto-Assessment Manikins (SAM)

Older adults with Parkinson's disease

Older adults with Alzheimer's disease with 65 years or older

Diagnostic Test: Mini Cognitive Examination (MCE)Diagnostic Test: Beck Depression Inventory-II (BDI-II)Diagnostic Test: Global Deterioration Scale (GDS)Diagnostic Test: Memory alteration test (M@T)Diagnostic Test: Spanish-Complutense Verbal Learning Test (TAVEC)Diagnostic Test: Barcelona test (BT)Diagnostic Test: Rey-Osterrieth Complex Figure Test (ROCFT)Diagnostic Test: Frontal assessment battery (FAB)Diagnostic Test: Positive and Negative Affect Scale (PANAS)Diagnostic Test: Auto-Assessment Manikins (SAM)

Interventions

Mini Cognitive Examination (MCE)DIAGNOSTIC_TEST

This test provides information on temporal and spatial orientation, fixation, concentration and calculation, memory and language and construction.

Healthy older adultsOlder adults with Alzheimer's diseaseOlder adults with Parkinson's disease
Beck Depression Inventory-II (BDI-II)DIAGNOSTIC_TEST

This test evaluates the absence or presence of depressive symptoms.

Healthy older adultsOlder adults with Alzheimer's diseaseOlder adults with Parkinson's disease
Global Deterioration Scale (GDS)DIAGNOSTIC_TEST

This scale measures the level of deterioration of the subject.

Healthy older adultsOlder adults with Alzheimer's diseaseOlder adults with Parkinson's disease
Memory alteration test (M@T)DIAGNOSTIC_TEST

In this test different memory subtypes are evaluated.

Healthy older adultsOlder adults with Alzheimer's diseaseOlder adults with Parkinson's disease
Spanish-Complutense Verbal Learning Test (TAVEC)DIAGNOSTIC_TEST

This test is used to assess immediate memory, deferred memory and learning ability.

Healthy older adultsOlder adults with Alzheimer's diseaseOlder adults with Parkinson's disease
Barcelona test (BT)DIAGNOSTIC_TEST

This test evaluates categorical evocation and verbal fluency. The categorical recall subtest consists of recalling the maximum number of words linked to a specific category "animals" in 1 minute. In the case of verbal fluency, the subject is asked to evoke the maximum number of words that begin with the letter "p" in 3 minutes.

Healthy older adultsOlder adults with Alzheimer's diseaseOlder adults with Parkinson's disease
Rey-Osterrieth Complex Figure Test (ROCFT)DIAGNOSTIC_TEST

In this test, the person must carefully copy a complex geometric drawing, which must be memorized later. The first part evaluates multiple cognitive processes such as planning, motor skills, working memory, and visual-constructive and spatial skills. In the second part, memory is evaluated.

Healthy older adultsOlder adults with Alzheimer's diseaseOlder adults with Parkinson's disease
Frontal assessment battery (FAB)DIAGNOSTIC_TEST

This test is a composite tool for assessing executive functions related to the frontal lobe.

Older adults with Parkinson's disease
Positive and Negative Affect Scale (PANAS)DIAGNOSTIC_TEST

It is a self-report questionnaire made up of 20 items (10 of positive affect and another 10 of negative affect) that the subject must answer, obtaining in this way a score in positive affectivity (AP subscale) and another in negative affectivity (AN subscale).

Healthy older adultsOlder adults with Alzheimer's diseaseOlder adults with Parkinson's disease
Auto-Assessment Manikins (SAM)DIAGNOSTIC_TEST

It is a self-report questionnaire that assesses the emotional response of the subject, in this case, through a mood induction task that plays different films scenes.

Healthy older adultsOlder adults with Alzheimer's diseaseOlder adults with Parkinson's disease

Eligibility Criteria

Age65 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Healthy older adults will be recruited from the Third Age Classrooms of the municipality of Quart de Poblet. * The older adults with mild Alzheimer's disease will be recruited through the Neurology Department of the General Hospital of Valencia. * The older adults with Parkinson's disease will be recruited through the Valencia Parkinson Association.

You may qualify if:

  • For the group of healthy older adults:
  • MEC score greater than 26 points.
  • GDS between 1 and 3.
  • For the mild EA group:
  • MEC score between 18 and 23 points.
  • GDS between 3 and 4.
  • For the EP group:
  • MEC score greater than 23 points.
  • GDS between 1 and 3.
  • FAB score equal to or less than 11 points.

You may not qualify if:

  • Participants cannot have:
  • Significant asymptomatic neurovascular disease
  • History of previous symptomatic stroke
  • Alcohol or drug abuse/dependence
  • Severe psychiatric symptoms
  • Depressive symptoms higher than mild

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

Related Publications (6)

  • Fernandez-Aguilar L, Ricarte J, Ros L, Latorre JM. Emotional Differences in Young and Older Adults: Films as Mood Induction Procedure. Front Psychol. 2018 Jul 3;9:1110. doi: 10.3389/fpsyg.2018.01110. eCollection 2018.

    PMID: 30018584RESULT

  • Carvalho S, Leite J, Galdo-Alvarez S, Goncalves OF. The Emotional Movie Database (EMDB): a self-report and psychophysiological study. Appl Psychophysiol Biofeedback. 2012 Dec;37(4):279-94. doi: 10.1007/s10484-012-9201-6.

    PMID: 22767079RESULT

  • Alves H, Koch A, Unkelbach C. Why Good Is More Alike Than Bad: Processing Implications. Trends Cogn Sci. 2017 Feb;21(2):69-79. doi: 10.1016/j.tics.2016.12.006. Epub 2017 Jan 4.

    PMID: 28063663RESULT

  • Alves H, Koch A, Unkelbach C. The differential similarity of positive and negative information - an affect-induced processing outcome? Cogn Emot. 2019 Sep;33(6):1224-1238. doi: 10.1080/02699931.2018.1549022. Epub 2018 Nov 26.

    PMID: 30475089RESULT

  • Reed AE, Carstensen LL. The theory behind the age-related positivity effect. Front Psychol. 2012 Sep 27;3:339. doi: 10.3389/fpsyg.2012.00339. eCollection 2012.

    PMID: 23060825RESULT

  • Nashiro K, Mather M. Effects of emotional arousal on memory binding in normal aging and Alzheimer's disease. Am J Psychol. 2011 Fall;124(3):301-12. doi: 10.5406/amerjpsyc.124.3.0301.

    PMID: 21977692RESULT

MeSH Terms

Conditions

Alzheimer DiseaseParkinson Disease

Interventions

Gene Expression

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathies

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

  • Juan C Melendez, Psychology

    University of Valencia

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 21, 2020

Study Start

March 2, 2020

Primary Completion

October 30, 2020

Study Completion

November 30, 2020

Last Updated

May 6, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

All the information of the study, as well as its results, will be shared in scientific publications and conferences related to the research area. The information that is intended to be published in scientific journals includes: 1) Study Protocol, 2) Statistical Analysis, 3) Informed Consent Form, 4) Clinical Study Results.

Locations

ES(1)