Exercise in Alzheimer's Disease: Functional Biomarkers
NCT07918417, Not applicable, Not yet recruiting, European University Miguel de Cervantes
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Exercise in Alzheimer's Disease: Functional Biomarkers | ClinicalTrials.gov |
| NCT number | NCT07918417 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 48 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | European University Miguel de Cervantes | ClinicalTrials.gov |
| Conditions | Alzheimer's Dementia (AD), Alzheimer Disease (AD) | ClinicalTrials.gov |
| Interventions | High load, Moderate load, Healthy adults - High load, Healthy adults - Moderate load | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Gut microbiome | Baseline, week 12 of intervention | Participants will collect a stool sample at home using a commercial collection kit (REAL Stool Sample Collection Microbiome kit, Durviz S.L., Valencia, Spain). Samples will be divided into three aliquots and stored at -80ºC within 2 hours of collection. Microbial DNA will be extracted and the gut microbiome will be analysed by next-generation sequencing of the 16S rRNA gene. | ClinicalTrials.gov |
| Primary | Inflammation indices - Systemic Inflammation Response Index | Baseline, week 1 of intervention, week 12 of intervention and week 12 of detraining | Fasting venous blood samples will be collected by a qualified nurse from the antecubital vein and complete blood count will be assessed by flow cytometry to assess the Systemic Inflammation Response Index (SIRI) . SIRI = (neutrophils × monocytes) / lymphocytes All cell counts will be expressed as ×10⁹ cells/L or equivalent. | ClinicalTrials.gov |
| Primary | Plasma biomarkers - Brain-derived neurotrophic factor | Baseline, week 1 of intervention, week 12 of intervention and week 12 of detraining | Plasma concentrations of Brain-derived neutrophic factor (BDNF) will be measured by Enzyme-Linked ImmunoSorbent Assay (ELISA). Fasting venous blood samples will be collected by a qualified nurse from the antecubital vein into EDTA-treated vacutainers and centrifuged at 1500g for 10 minutes. Plasma will then undergo a second centrifugation at 2500g for 15 minutes and be stored in cryogenic vials at -80ºC. Results will be expressed in pg/mL or ng/mL. | ClinicalTrials.gov |
| Primary | Inflammation indices - Aggregate Index of Systemic Inflammation | Baseline, week 1 of intervention, week 12 of intervention and week 12 of detraining | Fasting venous blood samples will be collected by a qualified nurse from the antecubital vein and complete blood count will be assessed by flow cytometry to assess the Aggregate Index of Systemic Inflammation (AISI). AISI = (neutrophils × monocytes × platelets) / lymphocytes All cell counts will be expressed as ×10⁹ cells/L or equivalent. | ClinicalTrials.gov |
| Primary | Plasma biomarkers - p-tau217 | Baseline, week 1 of intervention, week 12 of intervention and week 12 of detraining | Plasma concentrations of p-tau217 will be measured by ELISA. Fasting venous blood samples will be collected by a qualified nurse from the antecubital vein into EDTA-treated vacutainers and centrifuged at 1500g for 10 minutes. Plasma will then undergo a second centrifugation at 2500g for 15 minutes and be stored in cryogenic vials at -80ºC. Results will be expressed in pg/mL or ng/mL. | ClinicalTrials.gov |
| Primary | Plasma biomarkers - Klotho | Baseline, week 1 of intervention, week 12 of intervention and week 12 of detraining | Plasma concentrations of klotho will be measured by ELISA. Fasting venous blood samples will be collected by a qualified nurse from the antecubital vein into EDTA-treated vacutainers and centrifuged at 1500g for 10 minutes. Plasma will then undergo a second centrifugation at 2500g for 15 minutes and be stored in cryogenic vials at -80ºC. Results will be expressed in pg/mL or ng/mL. | ClinicalTrials.gov |
| Primary | Plasma biomarkers - Testosterone/cortisol ratio | Baseline, week 1 of intervention, week 12 of intervention and week 12 of detraining | Plasma ratio of testosterone/cortisol will be assessed by ELISA. Fasting venous blood samples will be collected by a qualified nurse from the antecubital vein into EDTA-treated vacutainers and centrifuged at 1500g for 10 minutes. Plasma will then undergo a second centrifugation at 2500g for 15 minutes and be stored in cryogenic vials at -80ºC. Results will be expressed in pg/mL or ng/mL. | ClinicalTrials.gov |
| Primary | Biological age | Baseline, week 1 of intervention, week 12 of intervention and week 12 of detraining | Fasting venous blood samples will be collected by a qualified nurse from the antecubital vein and analysed at the Hospital Universitario Río Hortega laboratory. PhenoAge clock based on crhonological age and nine blood biomarkers: albumin, creatinine, glucose, C-reactive protein, lymphocyte %, mean corpuscular volume, red blood cell distribution width, alkaline phosphatase and white blood count). PhenoAge acceleration (years) will be computed as the residual from regression PhenoAge on chronological age. | ClinicalTrials.gov |
| Secondary | Intrinsic capacity - Cognition | Baseline, week 1 of intervention (only verbal fluency), week 12 of intervention and week 12 of detraining | Cognition will be measured by Mini-Mental State Examination (0-35 points). | ClinicalTrials.gov |
| Secondary | Intrinsic capacity - Cognition | Baseline, week 1 of intervention (only verbal fluency), week 12 of intervention and week 12 of detraining | Cognition will also be measured by Clock Drawing Test (0-10 points) | ClinicalTrials.gov |
| Secondary | Intrinsic capacity - Cognition | Baseline, week 1 of intervention (only verbal fluency), week 12 of intervention and week 12 of detraining | Cognition will also be measured verbal fluency (words/min). | ClinicalTrials.gov |
| Secondary | Intrinsic capacity - Locomotion | Baseline, week 12 of intervention and week 12 of detraining | Locomotion will be assessed using the Short Physical Performance Battery (0-12 points). | ClinicalTrials.gov |
| Secondary | Intrinsic capacity - Locomotion | Baseline, week 12 of intervention and week 12 of detraining | Locomotion will be also assessed using the sit-to-stand muscle power (W) measured by PowerFrail app. | ClinicalTrials.gov |
| Secondary | Intrinsic capacity - Vitality | Baseline, week 12 of intervention and week 12 of detraining | Vitality will be measured by Mini-Nutritional Assessment (0-30 points). | ClinicalTrials.gov |
| Secondary | Intrinsic capacity - Vitality | Baseline, week 12 of intervention and week 12 of detraining | Vitality will also be measured by peak expiratory peak flow (L/min). | ClinicalTrials.gov |
| Secondary | Intrinsic capacity - Vitality | Baseline, week 12 of intervention and week 12 of detraining | Vitality will also be measured by handgrip strength (kg). | ClinicalTrials.gov |
| Secondary | Intrinsic capacity - Psychological | Baseline, week 12 of intervention and week 12 of detraining | Psychological domain will be assessed using the Cornell Scale for Depression in Dementia (0-38 points). | ClinicalTrials.gov |
| Secondary | Intrinsic capacity - Psychological | Baseline, week 12 of intervention and week 12 of detraining | Psychological domain will also be assessed using the Geriatric Depression Scale-10 (0-10 points). | ClinicalTrials.gov |
| Secondary | Intrinsic capacity - Psychological | Baseline, week 12 of intervention and week 12 of detraining | Psychological domain will also be assessed using the Neuropsychiatric inventory. | ClinicalTrials.gov |
| Secondary | Intrinsic capacity - Sensory capacity | Baseline, week 12 of intervention and week 12 of detraining | Sensory domain will be assessed by self-, clinician- or caregiver-reported vision and hearing problems | 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 2
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 |
|---|---|---|
| Clock Drawing Task | Secondary outcome | ConductCognition |
| Verbal Fluency | 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)