An observational study in Healthy Older Adults, Alzheimer's Disease and Parkinson's Disease, sponsored by University of Valencia. Withdrawn at 1 site in Spain. Open to participants aged 65 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-06.
Sponsored by University of Valencia · Observational
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.
Different neuropsychological tests will be used to assess the differences in cognitive function in the different groups, whose scores are expected to be lower in the group of older adults with Alzheimer's disease (AD) and older adults with Parkinson's disease (PD).
After studying the cognitive function in the different groups, we proceed to check through a task based on movie clips if there are also differences in the valence assessment (liking/disliking depending on the emotion induced by scenes from different films) and activation (excitement caused by each one of the movie scenes), hoping to find differences for the negative emotions taking into account the cognitive difficulties that both (the EA group and the EP group) may have for processing this type of cognitively more demanding information; instead, it is possible that the positivity effect continues to affect these patients so that for positive emotions there are no differences between the different groups.
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Inclusion Criteria:
For the group of healthy older adults:
For the mild EA group:
For the EP group:
General Exclusion Criteria:
Participants cannot have:
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 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 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)
This test provides information on temporal and spatial orientation, fixation, concentration and calculation, memory and language and construction.
This test evaluates the absence or presence of depressive symptoms.
This scale measures the level of deterioration of the subject.
In this test different memory subtypes are evaluated.
This test is used to assess immediate memory, deferred memory and learning ability.
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.
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.
This test is a composite tool for assessing executive functions related to the frontal lobe.
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).
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 5-10 minutes
Plan to share: No — 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.
This study is withdrawn, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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