Status:
COMPLETED
Management of Mild Cognitive Impairment Patients With Aloe and Crocus - BALSAM
Lead Sponsor:
Aristotle University Of Thessaloniki
Conditions:
Mild Cognitive Impairment
Eligibility:
All Genders
55-85 years
Phase:
NA
Brief Summary
There is accumulating evidence suggesting that Aloe vera and Crocus (saffron) may have a positive impact on conditions involving cognitive deficits, such as Mild Cognitive Impairment (MCI) and AD. Mor...
Detailed Description
OBJECTIVES OF THE TRIAL The objectives of this study are: To investigate the efficacy of Aloe Vera and Crocus as a disease course modifying treatment for MCI in a phase III double-blind placebo-cont...
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
- 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 :
December 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04436614
Start Date
December 17 2017
End Date
October 30 2019
Last Update
June 22 2020
Active Locations (1)
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1
Greek Alzheimer's Association and Related Disorders
Thessaloniki, Thessaloniki, Greece, 54248