Prospective Research on Identification of Dementia in Early Stages (P.R.I.D.E)
NCT07918638, Not yet recruiting, Don Mottola Medical Center
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Prospective Research on Identification of Dementia in Early Stages (P.R.I.D.E) | ClinicalTrials.gov |
| NCT number | NCT07918638 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 1,000 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Don Mottola Medical Center | ClinicalTrials.gov |
| Conditions | Mild Cognitive Impairment, Memory Disorders, Dementia | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Prevalence of Mild Cognitive Impairment at Baseline | At baseline (V0), during the initial clinical and neuropsychological assessment. | The proportion of enrolled participants with subjective memory complaints who meet the study-defined criteria for Mild Cognitive Impairment (MCI) at baseline, based on standardized clinical, neuropsychological, and functional assessments. MCI will be classified according to the operational criteria specified in the study protocol, considering objective cognitive impairment in relation to age and educational attainment, without substantial loss of independence in daily activities. Prevalence will be calculated as the number of participants classified as having MCI divided by the total number of enrolled participants with evaluable baseline assessments, multiplied by 100. Results will be expressed as a percentage with a 95% confidence interval. | ClinicalTrials.gov |
| Primary | Prevalence of Mild Cognitive Impairment Among Older Adults With Subjective Memory Complaints | At baseline (V0), during the initial clinical and neuropsychological assessment. | The prevalence of Mild Cognitive Impairment (MCI) will be calculated as the percentage of enrolled participants with subjective memory complaints who meet the study-defined criteria for MCI at baseline (V0). MCI classification will be based on standardized clinical, neuropsychological, and functional assessments, considering objective cognitive impairment relative to age and educational attainment, without substantial impairment of independence in daily activities. The numerator will be the number of participants classified as having MCI, and the denominator will be the total number of enrolled participants with evaluable baseline assessments. Results will be reported as a percentage with a 95% confidence interval. | ClinicalTrials.gov |
| Secondary | Incidence of Mild Cognitive Impairment During Follow-up | Baseline through 60 months, with annual assessments at 12, 24, 36, 48, and 60 months. | The occurrence of new cases of Mild Cognitive Impairment (MCI) among participants not classified as having MCI at baseline. Incident cases will be identified through standardized clinical, neuropsychological, and functional assessments according to the study-defined criteria. Cumulative incidence and incidence rates will be estimated with 95% confidence intervals, as appropriate. | ClinicalTrials.gov |
| Secondary | Incidence of Clinically Diagnosed Dementia During Follow-up | Baseline through 60 months, with annual ascertainment of documented clinical diagnoses. | The occurrence of new cases of clinically diagnosed dementia during follow-up, based on specialist diagnoses documented through routine healthcare pathways. The study will record the date of diagnosis and estimate cumulative incidence and time to dementia diagnosis using appropriate survival analysis methods. Research-based cognitive screening results alone will not be considered a clinical diagnosis of dementia. | ClinicalTrials.gov |
| Secondary | Change in Cognitive Performance Over Five Years | Baseline and 12, 24, 36, 48, and 60 months. | Longitudinal changes in cognitive performance will be assessed using standardized neuropsychological instruments, including the Mini-Mental State Examination (MMSE; score range 0-30) and the Montreal Cognitive Assessment (MoCA; score range 0-30), with higher scores indicating better cognitive performance. Changes from baseline and trajectories over time will be analyzed using repeated-measures statistical methods, including mixed-effects models. | ClinicalTrials.gov |
| Secondary | Prevalence of Subjective Memory Complaints in the Prescreened Population Description | At prescreening, before baseline enrollment. | The proportion of individuals reporting subjective memory complaints among all individuals assessed during the prescreening phase. Prevalence will be calculated as the number of individuals reporting subjective memory complaints divided by the total number of individuals with evaluable prescreening data, multiplied by 100. Results will be expressed as a percentage with a 95% confidence interval. | ClinicalTrials.gov |
| Secondary | Prevalence of Clinical and Cardiovascular Risk Factors at Baseline | At baseline (V0). | The prevalence of prespecified clinical, cardiovascular, metabolic, and lifestyle-related risk factors will be assessed at baseline. Variables include hypertension, diabetes mellitus, atrial fibrillation, obesity, ischemic heart disease, previous stroke, depressive symptoms, physical inactivity, and social isolation. The prevalence of each factor will be reported as a percentage of participants with evaluable data, with 95% confidence intervals. | ClinicalTrials.gov |
| Secondary | Association Between Risk Factors and Cognitive Performance at Baseline | Baseline and 12, 24, 36, 48, and 60 months. | Associations between prespecified demographic, clinical, cardiovascular, metabolic, and lifestyle-related factors and cognitive performance will be assessed using standardized neuropsychological test scores. Multivariable regression models will estimate adjusted associations, accounting for relevant confounders, including age, sex, and educational attainment. Results will be reported using regression coefficients or other appropriate effect estimates with 95% confidence intervals. | ClinicalTrials.gov |
| Secondary | Completeness of Study Data Collection | From baseline through 60 months. | Data completeness will be evaluated as the percentage of required study data fields completed among all applicable fields in the Case Report Forms. Completeness will be assessed across participating centers and scheduled study visits. Missing, unavailable, and inconsistent data will be identified through predefined quality control procedures. | ClinicalTrials.gov |
| Secondary | Reliability and Reproducibility of the Memory Complaint Questionnaire | During the methodological substudy, according to its predefined assessment schedule. | The psychometric properties of the Memory Complaint Questionnaire (MAC-Q) will be assessed in a dedicated methodological substudy. Internal consistency, test-retest reliability, and inter-rater agreement will be evaluated where applicable using appropriate reliability statistics, including Cronbach's alpha and intraclass correlation coefficients. Results will be reported with confidence intervals when appropriate. | 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 0
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 |
|---|
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)