Status:
UNKNOWN
Management of Dementia With Olive Oil Leaves - GOLDEN
Lead Sponsor:
Aristotle University Of Thessaloniki
Conditions:
Prevention
Eligibility:
All Genders
55-85 years
Phase:
NA
Brief Summary
Mild Dementia (Mild Dementia) is a state of mind disorder (memory, reason, attention, concentration, time orientation) with difficulty in the complex activities of everyday life (bank accounts, shoppi...
Detailed Description
Mild Dementia (Mild Dementia) is a state of mind disorder (memory, reason, attention, concentration, time orientation) with difficulty in the complex activities of everyday life (bank accounts, shoppi...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 10 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04440020
Start Date
January 5 2019
End Date
April 10 2021
Last Update
June 19 2020
Active Locations (1)
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1
Greek Associoation of Alzheimer'S Disease and Related Disorders
Thessaloniki, Greece, 54248