Cognitive brain circuits and the spread of tau in vivo in humans
Key facts
- Where
- Leuven, BelgiumSee the site
- Phase
- 4. fázis
Where in Belgium
- UZ LeuvenLeuven, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UZ Leuven
- Trial code
- EU 2024-511613-38-01
- Record updated
- 2024. augusztus 27.
- Original description
To determine how the spread of tau aggregates in the different phases of Alzheimer disease (AD) (the preclinical, the prodromal, and the early dementia phase) affects the functional organization of the language circuit.Read full original descriptionShow less
Cognitive brain circuits and the spread of tau in vivo in humans.
To determine how the spread of tau aggregates in the different phases of Alzheimer disease (AD) (the preclinical, the prodromal, and the early dementia phase) affects the functional organization of the language circuit.
Inclusion: 40 patients with mild to moderate clinically probable AD according to the National Institute of Aging (NIA)-Alzheimer's Association (AA) diagnostic criteria [22], and an MMSE of 16 or higher and a Clinical Dementia Rating scale total score of 0.5 or 1; 40 patients with amnestic MCI due to AD according to the NIA-AA diagnostic criteria [3], an MMSE 25 or higher, and a Clinical Dementia Rating scale total score of 0.5; 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); 40 matched amyloid-negative cognitively intact healthy controls. These subjects will be matched in age, education and gender to the three first cohorts.
Exclusion: Women of childbearing potential. Female subjects who are of childbearing potential are eligible to participate if they use a highly effective method of contraception that is either user-dependent (combined (estrogen- and progestogen-containing) hormonal contraception or progestogen-only hormonal contraception associated with inhibition of ovulation) or user-independent (implantable progestogen-only hormonal contraception associated with inhibition of ovulation), vasectomized partner or sexual abstinence). Female subjects are not considered of childbearing potential if they are surgically sterile (hysterectomy or bilateral salpingectomy/oophorectomy), or postmenopausal for at least 1 year prior to screening (defined as no menses for more than 12 months without an alternative medical cause); Female partner of male subjects must be surgically sterile (hysterectomy or bilateral salpingectomy/oophorectomy or bilateral tubal occlusion/ligation) or postmenopausal for at least 1 year prior to screening; Participants with significant medical, neurological or psychiatric comorbidity; Individuals with a history of epilepsy or a known family history of epilepsy will be excluded from the 40 Hz stimulation paradigm; Patients who are unable to provide written informed consent; 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.