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Taking people in BelgiumPhase 4

Studies how tau spread affects brain language circuits in early Alzheimer disease

Examines how tau protein spread alters language brain networks in people with early Alzheimer disease.

Key facts

Who runs it
UZ Leuven
Where
Leuven, BelgiumSee the site
Registry title
Cognitive brain circuits and the spread of tau in vivo in humans
Status
Recruiting
Phase
Phase 4
People taking part
160 people, planned
Started
18 May 2018
Expected to end
20 Nov 2034
Type of study
Interventional
Record updated
27 August 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with Alzheimer disease, people with early memory loss due to Alzheimer disease, and healthy people with and without amyloid in the brain.

Age
The registry lists 18 Years as the minimum age. The healthy amyloid-positive group is described as aged 55-80 years.
Sex
Both women and men can join.
Disease stage
Mild to moderate probable Alzheimer disease (MMSE 16 or higher, Clinical Dementia Rating total score 0.5 or 1), or amnestic mild cognitive impairment due to Alzheimer disease (MMSE 25 or higher, Clinical Dementia Rating total score 0.5).
Biomarker or test result
One healthy group must be amyloid-positive and another healthy group must be amyloid-negative. Both must be cognitively intact.

Main reasons for not taking part

  • Cannot give written informed consent
  • Significant medical, neurological or psychiatric illness
  • Structural brain lesions on MRI such as large-vessel strokes, macrohemorrhage sequelae, arachnoidal cysts or posttraumatic lesions
  • Women who could become pregnant and do not use a highly effective method of contraception
  • History of epilepsy or known family history of epilepsy (excluded from the 40 Hz stimulation part)

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Belgium

  • UZ LeuvenLeuven, BelgiumTaking people

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Cognitive brain circuits and the spread of tau in vivo in humans.
Plain-language title
Studies how tau spread affects brain language circuits in early Alzheimer diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
27 August 2024