Trial · NCT06362707
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cognition | The cognitive battery will be performed at baseline and every three months until last visit, supported by trial staff (up to 1 year). | The primary outcome will be the FLAME computer-based working memory composite comprised of tests of working memory and episodic memory |
| Primary | Brain metabolism | The outcome will be change in FDG-PET between baseline and at 12 months. | FDG-PET is a highly sensitive means of determining brain metabolism and has been accepted as a good proxy measure of synaptic function. Importantly, FDG-PET based measures of brain metabolism correlate well with cognitive decline in AD, better than amyloid plaques. Data from the Alzheimer's Disease Neuroimaging Initiative (ADNI) study suggest that FDG PET has good power to detect a 25% treatment effect over 12 months |
| Secondary | Plasma levels of ptau217 | Collection of blood samples will occur at baseline and the 12-month visit. | This study involves the collection of blood samples, following standardized procedures. Blood markers associated with Alzheimer's disease (AD) will be analyzed for typical AD features to fulfill inclusion criteria. The primary focus will be on examining changes in levels of plasma ptau217 and nfl, measured in pg/mL. |
| Secondary | Plasma levels of nfl | Collection of blood samples will occur at baseline and the 12-month visit. | This study involves the collection of blood samples, following standardized procedures. Blood markers associated with Alzheimer's disease (AD) will be analyzed for typical AD features to fulfill inclusion criteria. The primary focus will be on examining changes in levels of plasma ptau217 and nfl, measured in pg/mL. |
| Secondary | Levels of cerebrospinal Aβ1-40 and Aβ1-42 | Collection of CSF samples will occur at baseline and the 12-month visit. | This study involves the collection of cerebrospinal fluid (CSF) samples, following standardized procedures. CSF markers associated with Alzheimer's disease (AD) will be analyzed for typical AD features, measured in pg/mL. |
| Secondary | Levels of cerebrospinal tau and p-tau | Collection of CSF samples will occur at baseline and the 12-month visit. | This study involves the collection of cerebrospinal fluid (CSF) samples, following standardized procedures. CSF markers associated with Alzheimer's disease (AD) will be analyzed for typical AD features, measured in pg/mL. |
| Secondary | Blood pressure (Safety assessments) | Conducted at all visits throughout the 12-month duration of the study. Additionally, the Columbia Suicide Severity Rating Scale (C-SSRS) will be administered at screening, month 6, and month 12 | Safety measurements, blood pressure measured in millimetres of mercury (mmHg). |
| Secondary | Pulse (Safety assessments) | Conducted at all visits throughout the 12-month duration of the study. | Safety measurements, including pulse frequency in beats per minute (bpm). |
| Secondary | Urine testing (Safety assessments) | Conducted at baseline and all visits throughout the 12-month duration of the study. | Urine will be tested with a dipstick test to explore proteinuria or hematuria. |
| Secondary | Blood urea nitrogen (BUN) (Safety assessments) | Conducted at baseline and all monthly visits throughout the 12-month duration of the study. | Measured in blood in mmol/L |
| Secondary | Potassium (Safety assessments) | Conducted at baseline and all monthly visits throughout the 12-month duration of the study. | Measured in blood in mmol/L |
| Secondary | Sodium (Safety assessments) | Conducted at baseline and all monthly visits throughout the 12-month duration of the study. | Measured in blood in mmol/L |
| Secondary | Calcium (Safety assessments) | Conducted at baseline and all monthly visits throughout the 12-month duration of the study. | Measured in blood in mmol/L |
| Secondary | Glucose (Safety assessments) | Conducted at baseline and all monthly visits throughout the 12-month duration of the study. | Measured in blood in mmol/L |
| Secondary | Hemoglobin (Safety assessments) | Conducted at baseline and all monthly visits throughout the 12-month duration of the study. | Measured in blood in g/dL |
| Secondary | Creatinine (Safety assessments) | Conducted at baseline and all monthly visits throughout the 12-month duration of the study. | Measured in blood in μmol/L |
| Secondary | Total and direct bilirubin (Safety assessments) | Conducted at baseline and all monthly visits throughout the 12-month duration of the study. | Measured in blood in μmol/L |
| Secondary | CRP (C-reactive protein) (Safety assessments) | Conducted at baseline and all monthly visits throughout the 12-month duration of the study. | Measured in blood in mg/L |
| Secondary | Aspartate aminotransferase (AST) (Safety assessments) | Conducted at baseline and all monthly visits throughout the 12-month duration of the study. | Measured in blood in U/L (units per liter) |
| Secondary | Serum glutamic-oxaloacetic transaminase (SGOT) (Safety assessments) | Conducted at baseline and all monthly visits throughout the 12-month duration of the study. | Measured in blood in U/L (units per liter) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06362707/registered