Status:
UNKNOWN
Management of Mild Cognitive Impairment Patients With Extra Virgin Olive Oil - MICOIL
Lead Sponsor:
Greek Alzheimer's Association and Related Disorders
Conditions:
Mild Cognitive Impairment
Eligibility:
All Genders
55-85 years
Phase:
PHASE2
Brief Summary
There is accumulating evidence suggesting that olive oil may have a positive impact on conditions involving cognitive deficits, such as MCI and AD. More specifically, these beneficial effects are most...
Detailed Description
OBJECTIVES OF THE TRIAL The objectives of this study are: * To investigate the efficacy of freshly pressed EVOO as a disease course modifying treatment for mild cognitive impairment in a phase III d...
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 24-30
- CDR(sum of boxes) \>= 0,5
- Diagnosis: Mild Cognitive Impairment (amnestic plus multi-domain)
- Geriatric Depression Scale (GDS) \<6
- Hachinski Modified Ischemic scale \<= 4
- Stability of Permitted Medications for 4 weeks
- Years of education: \>= 5
- Proficient language fluency
- Have a study partner with 10+ hr/wk contact (can be in person and telephone), accompanies to visits
- 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
- Medications across the study
- 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 :
November 9 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2019
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03362996
Start Date
November 9 2016
End Date
May 15 2019
Last Update
January 8 2018
Active Locations (1)
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1
Greek Association of Alzheimer's Disease and Related Disordeers
Thessaloniki, Greece, 54248