Health Technology Assessment of Diagnostic Approaches in Alzheimer's Disease
NCT01450891, Completed, Maastricht University Medical Center
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Health Technology Assessment of Diagnostic Approaches in Alzheimer's Disease | ClinicalTrials.gov |
| NCT number | NCT01450891 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Enrollment | 304 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Maastricht University Medical Center | ClinicalTrials.gov |
| Conditions | Neurodegenerative Diseases, Memory Disturbances | ClinicalTrials.gov |
| First posted | 2011-10-12 | ClinicalTrials.gov |
| Last updated | 2015-05-28 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Diagnostic accuracy of Magnetic Resonance Imaging (MRI) | baseline | Diagnostic test accuracy (in terms of sensitivity and specificity) of three MRI markers (Whole brain and hippocampal volume, white matter integrity, and functional connectivity) is determined by relating the particular marker to a reference diagnosis. The reference diagnosis is determined by a consensus procedure among experts based on clinical information on the course of symptoms over a two-year time period. | ClinicalTrials.gov |
| Primary | Change in cognition at 2 years | baseline, 1 year follow up, 2 year follow up | Measured by the Mini-mental state examination (MMSE). | ClinicalTrials.gov |
| Primary | Change in dementia severity at 2 years | baseline, 1 year follow up, 2 year follow up | Measured by the clinical dementia rating (CDR) scale. | ClinicalTrials.gov |
| Primary | Change in quality of life at 2 years | baseline, 3 months follow up, 1 year follow up, 2 year follow up | Measured by the Euro-Qol-5D both by the patient and caregiver and measured by the Quality of life Alzheimer's disease state (QoL-AD) both by the patient and caregiver. | ClinicalTrials.gov |
| Primary | Health care resource use during 2 years | baseline, 3 months follow up, 1 year follow up, 2 year follow up | By means of questionnaires the health care resource usage is measured by the Resource Utilization in Dementia-questionnaire (RUD-lite) over a period of 2 years using 4 measurement moments to interpolate the data. | ClinicalTrials.gov |
| Primary | Change in productivity at 2 years | baseline, 3 months follow up, 1 year follow up, 2 year follow up | Work status, income, and productivity losses of both the patient and caregiver are assessed by the adjusted PRODISQ (PROductivity and DISease Questionnaire). The consequences of informal caregiving on paid or unpaid work are assessed by the Health and Labour Questionnaire. | ClinicalTrials.gov |
| Primary | Diagnostic accuracy of cerebrospinal fluid (CSF) | baseline | Diagnostic test accuracy (in terms of sensitivity and specificity) of three CSF markers (CSF total tau, CSF phosphorylated tau, and CSF Aβ1-42) is determined by relating the particular marker to a reference diagnosis. The reference diagnosis is determined by a consensus procedure among experts based on clinical information on the course of symptoms over a two-year time period. | ClinicalTrials.gov |
| Secondary | Demographic changes at 2 years | baseline, 1 year follow up, 2 year follow up | Course of cognitive symptoms, Civil status, and Living situation are assessed. | ClinicalTrials.gov |
| Secondary | General clinical changes at 2 years | baseline, 1 year follow up, 2 year follow up | Smoking behaviour, alcohol intake, length, weight, blood pressure, neuropsychological problems, and co-morbidities are assessed. | ClinicalTrials.gov |
| Secondary | Change in behavioural and psychological problems at 2 years | baseline, 1 year follow up, 2 year follow up | Measured by the Neuropsychiatric Inventory (NPI). | ClinicalTrials.gov |
| Secondary | Change in basic and instrumental activities in daily activities at 2 years | baseline, 1 year follow up, 2 year follow up | Measured by the Disability assessment for Dementia (DAD). | ClinicalTrials.gov |
| Secondary | Change in depression at 2 years | baseline, 1 year follow up, 2 year follow up | Measured by the geriatric depression scale 15 (GDS-15). | ClinicalTrials.gov |
| Secondary | Change in cognitive functioning at 2 years | baseline, 1 year follow up, 2 year follow up | A neuropsychological examination is performed using the: * Rey's Verbal Learning Test, Visual Association Test, and Digit-Span to assess memory; * Letter Digit Substitution Test to assess mental processing rate; and * Stroop Color-Word Test and Trail Making Test to assess attention, concentration and interference. | ClinicalTrials.gov |
| Secondary | Change in sense of competence at 2 years | baseline, 1 year follow up, 2 year follow up | Measured by the Sense of Competence Questionnaire (SoCQ). | ClinicalTrials.gov |
| Secondary | Change in Care-related quality of life | baseline, 3 months follow up, 1 year follow up, 2 year follow up | Assessed by the CarerQol by the informal caregiver. | 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 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 22883691 | BACKGROUND | PubMed |
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 5
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 |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary 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)