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:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT04440020
Eligibility Criteria:
Inclusion Criteria:
* Memory Complaints
* Abnormal memory function documented by scoring 1 SD below the age-adjusted mean on the Logical Memory II subscale, (Delayed Paragraph Recall) from the Wechsler Memory Scale-R.
* MMSE 18-24
* CDR(sum of boxes) \>= 0,5
* Diagnosis: Mild Dementia (Alzheimer's Dementia)
* Geriatric Depression Scale (GDS) \<6
* Hachinski Modified Ischemic scale \<= 4
* Stability of Permitted Medications for 4 weeks
* Years of education: \>= 5
* Proficient language fluency
* Compliance
Exclusion Criteria:
* Visual and auditory acuity inadequate for neuropsychological testing
* Enrollment in other trials or studies not compatible with MICOIL
* History of significant neurological or psychiatric illnesses or presence of other diseases precluding enrollment.
* Use of forbidden medications (listed below)
* Ferromagnetic implants and devices (including implants or devices held in place by sutures, granulation or ingrowth of tissue, fixation devices, or by other means) not eligible for MRI scanning. Brain malformation or other conditions that may complicate lumbar puncture
Excluded Medication:
* Antidepressants with anti-cholinergic properties.
* Regular use of narcotic analgesics (\>2 doses per week) within 4 weeks of screening.
* Use of neuroleptics with anti-cholinergic properties (e.g., chlorpromazine, thioridazine) within 4 weeks of screening.
* Chronic use of other medications with significant central nervous system anticholinergic activity within 4 weeks of screening (e.g., diphenhydramine).
* Use of Anti-Parkinsonian medications (including Sinemet, amantadine, bromocriptine, pergolide, selegeline) within 4 weeks of screening.
* Participation in any other investigational drug study within 4 weeks of screening (individuals may not participate in any drug study while participating in this protocol).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
85 Years
Study:
NCT04440020
Study Brief:
Protocol Section:
NCT04440020