BridgeMD
Cognitive brain circuits and the spread of tau in vivo in humans
EU CTIS ID: 2024-511613-38-01
What this study is testing
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.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Patients who are unable to provide written informed consent
- Participants with significant medical, neurological or psychiatric comorbidity
- 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.
- 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.
- Individuals with a history of epilepsy or a known family history of epilepsy will be excluded from the 40 Hz stimulation paradigm
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.