Cognitive brain circuits and the spread of tau in vivo in humans
- Conditions
- Alzheimer diseaseTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2018-001257-27-BE
- Lead Sponsor
- KU Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
The study population consists of four cohorts, of 40 subjects each. The lower age limit will be 50 years of age and the upper limit 85.
The study groups will consist of:
1. 40 patients with mild to moderate clinically probable AD according to the National Institute of Aging (NIA)-Alzheimer's Association (AA) diagnostic criteria [29], and an MMSE of 16 or higher and a Clinical Dementia Rating scale total score of 0.5 or 1. Patients will be recruited via the memory clinic of the University Hospitals Leuven (UZ Leuven).
2. 40 patients with amnestic MCI due to AD according to the NIA-AA diagnostic criteria [5], an MMSE 25 or higher, and a Clinical Dementia Rating scale total score of 0.5, recruited via the memory clinic UZ Leuven (total number of amnestic MCI patients currently in follow-up = 64).
3. 40 amyloid-positive cognitively intact healthy controls, recruited via a longitudinal community-recruited cohort that is followed at the Laboratory for Cognitive Neurology (see below) (mean age = 68.4 6.4, range 55-80 years). One of the key inclusion criteria is neuropsychological test scores within the published norms at baseline.
4. 40 matched amyloid-negative cognitively intact healthy controls, recruited from the community following the same procedures as for our earlier cohort. These subjects will be matched in age, education and gender to the three first cohorts.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 106
Participants with significant medical, neurological or psychiatric comorbidity will be excluded. Structural lesions on MRI, such as large-vessel strokes, sequellae of macrohemorrhages, arachnoidal cysts, and posttraumatic lesions, will be an exclusion criterion. White matter lesions will be allowed.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to determine how changes in the functional brain network for language relate to the hierarchical spread of tau aggregates;Secondary Objective: To determine the topographical spread of tau across different stages (preclinical, prodromal, early dementia stage) of Alzheimer's disease;Primary end point(s): Nodal activity levels (response amplitude) and connectivity (path length, clustering coefficient, degree and betweenness centrality) of the posterior superior temporal sulcus, posterior middle temporal gyrus and the anterior supramarginal gyrus in relation to the presence of aggregated tau. ;Timepoint(s) of evaluation of this end point: within 3 months after study inclusion
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Number of subject clusters that can be reliably defined based on hierarchical clustering analysis of the scans and the corresponding topography of the spread of tau<br>;Timepoint(s) of evaluation of this end point: Within 3 months after study inclusion