TRIAD - Tracking Risk in Integrated Alzheimer's Diagnostics.
NCT07399418, Recruiting, Istituti Clinici Scientifici Maugeri SpA
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | TRIAD - Tracking Risk in Integrated Alzheimer's Diagnostics. | ClinicalTrials.gov |
| NCT number | NCT07399418 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Istituti Clinici Scientifici Maugeri SpA | ClinicalTrials.gov |
| Conditions | Cognitive Decline | ClinicalTrials.gov |
| First posted | 2026-02-10 | ClinicalTrials.gov |
| Last updated | 2026-02-17 | ClinicalTrials.gov |
Registered outcomes 42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Mini Mental State Examination (MMSE) | Baseline | This test is used for rapid screening of overall cognitive functioning. It consists of eleven items in different cognitive areas to obtain an overall score of cognitive functioning. Total scores range from 0 to 30 points. Lower scores indicate worse performances. N.B. This information will be collected only for the patients. | ClinicalTrials.gov |
| Primary | Montreal Cognitive Assessment (MoCA) | Baseline | It is a cognitive screening test used in the assessment of dementia. The MoCA consists of several items that assess the following cognitive functions: visuospatial and executive functions, naming, attention, language, abstraction, memory, and spatial-temporal orientation. The score ranges from 0 to 30. Lower scores indicate worse performances. N.B. This information will be collected only for the patients. | ClinicalTrials.gov |
| Primary | Mental Deterioration Battery (MDB) | Baseline | It is a battery of neuropsychological tests developed to assess cognitive decline, often used to diagnose and monitor cognitive disorders such as AD. The battery includes verbal memory tests (Rey's 15 words, immediate and delayed recall), phonemic verbal fluency, sentence construction, Raven's Progressive Matrices, immediate visual memory, freehand drawing copying, and programmed drawing copying. Each test is corrected independently. Lower scores indicate worse performances. N.B. This information will be collected only for the patients. | ClinicalTrials.gov |
| Primary | Free and Cue Selective Reminding Test (FCSRT) | Baseline | is used to assess episodic memory and recall ability. The test consists of four main phases: learning phase, free recall, guided recall, and delayed recall. The final score is calculated by adding the scores from the different phases. Poor free recall but good guided recall suggests a retrieval deficit, which is compatible with normal aging. On the other hand, a low score in both conditions indicates memory consolidation difficulties. N.B. This information will be collected only for the patients. | ClinicalTrials.gov |
| Primary | Frontal Assessment Battery (FAB) | Baseline | It is a test consisting of 6 items that measure conceptualization of similarity, lexical fluency in phonemic mode, motor planning, conflicting instructional responses, the go-no go task, and grasping behavior. Each item is scored on a scale from 0 to 3, with a maximum raw score of 18 points. Lower scores indicate worse performances. N.B. This information will be collected only for the patients. | ClinicalTrials.gov |
| Primary | Digit Span forward-backward | Baseline | It is used to assess short-term verbal memory and verbal working memory. The test consists of two different tasks. The first task (forward) assesses short-term verbal memory and requires the assessor to read a sequence of numbers that the patient must then repeat in the same order. The second test (backward) assesses verbal working memory and requires the patient to repeat the sequence of numbers in reverse order to that read by the evaluator. The sequences gradually increase in difficulty, starting from a minimum of three digits up to a maximum of nine for the forward test and eight for the backward test. Lower scores indicate worse performances. N.B. This information will be collected only for the patients. | ClinicalTrials.gov |
| Primary | Span di cubi forward-backward | Baseline | Psychometric tool used to assess short-term visuospatial memory and visuospatial working memory. The first test (forward) assesses short-term visuospatial memory and requires the evaluator to touch a sequence of cubes arranged on a board and the patient to repeat the sequence by touching the cubes in the same order. The second test (backward) assesses visuospatial working memory and requires the examiner to tap a sequence of cubes, which the patient must then repeat in reverse order. The sequences of cubes to be tapped gradually increase in difficulty, starting from a minimum of three cubes up to a maximum of nine for the forward test and eight for the backward test. Lower scores indicate worse performances. N.B. This information will be collected only for the patients. | ClinicalTrials.gov |
| Primary | Phonemic fluency | baseline | It assesses vocabulary access and verbal fluency based on phonemic cues. It consists of three tests in which the patient must generate as many words as possible beginning with a specific letter (F, A, and S) in 60 seconds for each letter. The total raw score is the sum of the number of correct words generated for each letter within the time limit. Lower scores indicate worse performances. N.B. This information will be collected only for the patients. | ClinicalTrials.gov |
| Primary | Semantic fluency | Baseline | Twop different test are included. Both assesse vocabulary access and verbal fluency on semantic prompts. Both consist of rials in which the patient must generate as many words as possible belonging to each of the following categories. For the first test categories are colors, animals, and fruits. instead, for the secon test categories are birds and pices of fornuture. The time allowed for each category is 60 seconds. The total raw score is the sum of the number of correct words generated for each letter within the time limit. Lower scores indicate worse performances. N.B. This information will be collected only for the patients. | ClinicalTrials.gov |
| Primary | Trail Making Test (TMT) A-B | Baseline | A tool used to assess divided attention, visuomotor coordination, and the ability to alternate conceptual settings. Specifically, this test consists of two trials. Trial A (TMT-A) requires the patient to connect a list of randomly arranged numbers in ascending order as quickly as possible. Test B (TMT-B), on the other hand, requires the subject to connect alternating numbers and letters in the shortest possible time. The letters must be connected in alphabetical order and the numbers in ascending order. Shorter completion times indicate better performances. N.B. This information will be collected only for the patients. | ClinicalTrials.gov |
| Primary | Stroop test | Baseline | It assesses selective attention and executive functions, with particular focus on inhibitory interference and cognitive flexibility. The test is divided into three parts of increasing difficulty. The first test consists of reading a list of colors. The second test requires the patient to name the color of the ink with which the circles are printed. Finally, in the third test, the patient is asked to name the color of the ink with which the names of the different colors are written. The patient is asked to try as quickly as possible and to continue the exercise even if they make mistakes. At the end, two raw scores are obtained: one for the completion time (with shorter completion times show better performances) and one for the number of mistakes made (with lower errors indicating a better performance) N.B. This information will be collected only for the patients. | ClinicalTrials.gov |
| Primary | Rey-Osterrieth Complex figure (ROCF) | Baseline | This test consists of two different tasks. The first, ROCF copy, assesses visuospatial and motor planning skills. It consists of copying a complex figure as accurately as possible. The second test, or ROCF with 15-minute recall, assesses long-term visuospatial memory. Fifteen minutes after being shown a complex figure-a period during which the subject performs other non-interfering tasks-the subject is asked to reproduce the figure without being able to review it. For both of the trials, the total score is from o to 36. Lower scores indicate worse performances. N.B. This information will be collected only for the patients. | ClinicalTrials.gov |
| Primary | Multiple Features Target Target Cancellation | Baseline | This test evaluates executive functioning. The patient is given a sheet containing a grid of visual stimuli, including both targets and distractors. They are then asked to cross out all the targets that correspond to the target stimulus. The execution time, the number of correctly identified targets, and the number of errors (number of distractors crossed out) are then recorded. These last two data points are then combined to calculate the accuracy index. Lower scores indicate worse performances. N.B. This information will be collected only for the patients. | ClinicalTrials.gov |
| Primary | Clock Drawing Test (CDT) | Baseline | It is a brief neuropsychological screening tool used to assess global cognitive functioning, with particular sensitivity to executive functions, visuospatial abilities, attention, and planning. It includes three trials: a free-drawing condition, a pre-drawn circle condition, and a copy condition. Lower scores indicate worse performances. N.B. This information will be collected only for the patients. | ClinicalTrials.gov |
| Primary | Naming of colored photographs | Baseline | It is a neuropsychological test used to assess lexical and semantic abilities, specifically object naming based on visual stimuli. The test consists of presenting a series of images depicting common objects, which the participant is required to name verbally. Lower scores indicate worse performances. N.B. This information will be collected only for the patients. | ClinicalTrials.gov |
| Primary | Episodic Memory Score | Baseline | It is a composite index derived from standardized episodic memory tasks. It is designed to provide a synthetic and robust estimate of episodic memory functioning, reducing task-specific variability and enhancing sensitivity to early memory impairment. Lower scores indicate worse performances. N.B. This information will be collected only for the patients. | ClinicalTrials.gov |
| Primary | Semantic-Phonological Delta | Baseline | It is a difference score calculated from verbal fluency tasks by subtracting phonological fluency performance from semantic fluency performance. This index captures the relative imbalance between semantic memory and executive-phonological processes. A reduced or negative delta reflects a disproportionate impairment in semantic fluency relative to phonological fluency. N.B. This information will be collected only for the patients. | ClinicalTrials.gov |
| Primary | Patient Health Questionnaire 9 (PHQ-9) | Baseline | It is a psychological screening tool used to assess the severity of symptoms typical of major depressive disorder. The patient responds to the items by thinking about the frequency with which they have experienced the difficulties described in the last two weeks. Each item is rated on a 4-point Likert scale ranging from 0 (never) to 3 (almost every day). The total score, out of a maximum of 27 points, is given by the sum of the scores obtained for each item. Five levels of clinical severity have been identified, based on specific cut-offs: no depression (0-4 points), mild depression (5-9 points), moderate depression (10-14 points), moderately severe depression (15-19 points), and severe depression (20 or more points). N.B. This information will be collected both for patients and caregivers. | ClinicalTrials.gov |
| Primary | Generalized Anxiety Disorder (GAD-7) | Baseline | It is a psychological screening tool used to assess the severity of symptoms typical of generalized anxiety disorder. It is a self-report questionnaire consisting of 7 items. The patient responds to the items by thinking about the frequency with which they have experienced the difficulties described in the last two weeks. Each item is rated on a 4-point Likert scale ranging from 0 (never) to 3 (almost every day). The total score, out of a maximum of 21 points, is given by the sum of the scores obtained for each item. Four levels of clinical severity have been identified, based on specific cut-offs: no anxiety (0-4 points), mild anxiety (5-9 points), moderate anxiety (10-14 points), and severe anxiety (15 or more points). N.B. This information will be collected both for patients and caregivers. | ClinicalTrials.gov |
| Primary | Perceived Stress Scale 10 (PSS-10) | Baseline | It is a scale used to measure an individual's perceived stress level over the past four weeks. The aim is not to measure 20 specific areas, but rather the extent to which a person perceives their life as unpredictable or difficult to manage. The short version, in its Italian translation, has 10 items, each of which is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score (40 points) is given by the sum of the scores obtained for each item. N.B. This information will be collected both for patients and caregivers. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 11
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Category Fluency | Primary outcome | ConductCognition |
| Clock Drawing Task | Primary outcome | ConductCognition |
| Complex Figure Copy and Recall | Primary outcome | ConductCognition |
| Digit Span Test | Primary outcome | ConductCognition |
| Go/No-Go Task | Primary outcome | ConductCognition |
| Matrix Reasoning | Primary outcome | ConductCognition |
| Selective Reminding Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)