Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT01574456
Eligibility Criteria:
Inclusion Criteria:
Patients with AD:
* Informed consent before participation in the study
* Received standard diagnostic procedure according to the Parelsnoer Initiative procedure
* Diagnosed with dementia of the Alzheimer's type
* Clinical dementia rating (CDR) of 1, which means a mild to moderate stage of dementia
* MMSE ≥ 20 and patients are mentally competent (in general, individuals with an MMSE ≥ 18 are considered mentally competent)
Patients with prodromal AD:
* Informed consent before participation in the study
* Received standard diagnostic procedure according to the Parelsnoer Initiative procedure
* Diagnosis of prodromal dementia according to the Dubois criteria (16)
* CDR of 0.5, which suggests a very mild stage of dementia
* Memory impairment defined as Delayed Recall on Verbal Learning Test (15 WLT) \< 1.5 SD
* MMSE ≥ 20 and patients are mentally competent.
* Medial temporal lobe atrophy scale MTA ≥ 1 (17) OR abnormal levels of Aß42, t-tau or p-tau
Healthy participants:
* Informed consent before participation in the study
* No Diagnosis of dementia, prodromal dementia, or mild cognitive impairment.
* MMSE ≥ 26
* No substantial memory complaints (according to participant)
* Age, gender and education is matched to the patient groups.
Exclusion Criteria:
* Contraindications for scanning (e.g. brain surgery, cardiac pacemaker, metal implants, claustrophobia, large body tattoos)
* Contraindications for contrast agent Gadovist (renal failure) as determined by the estimated Glomular Filtration Rate eGFR \< 30 mL/min.
* Major vascular disorders (e.g. stroke, heart disease)
* Psychiatric or neurological disorders: Major depression (\< 12 months); history of schizophrenia; bipolar disorder; psychotic disorder NOS or treatment for a psychotic disorder (\< 12 mnd); cognitive impairment due to alcohol abuse; epilepsy; Parkinson's disease; MS; brain surgery; brain trauma; electroshock therapy; kidney dialysis; Meniere's disease; and brain infections.
* Structural abnormalities of the brain
* Cognitive impairment due to alcohol/drug abuse
* Absence of reliable informant (for patient groups)
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT01574456
Study Brief:
Protocol Section:
NCT01574456