Mild Cognitive Impairment Clinical Trial
— BALSAMOfficial title:
Randomized, Double Blind, Placebo Controlled Prospective Study, to Evaluate the Effect of Aloe Vera and Crocus in Patiens With Mild Cognitive Impairment
Verified date | June 2020 |
Source | Aristotle University Of Thessaloniki |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. More specifically, aloe vera gel contains powerful antioxidants, which belong
to a large family of substances known as polyphenols. Aloe has also been proven to possess
cholinergic and cognitive enhancing capabilities. Crocus is deeper studied and it shows
promising results in neuroprotection against AD through various suggested mechanisms, such as
the enhancement of amyloid-beta clearance in the brain and the inhibition of neurofibrillary
tangles formation. For this reason, it would be interesting to study the effects of
combination of Aloe Vera and Crocus . The aim of the study is to evaluate the beneficial
effect of Aloe Vera and Crocus (saffron) in comparison with Aloe (simple)on patients
diagnosed with mild cognitive impairment MCI.
Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel
Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Status | Completed |
Enrollment | 100 |
Est. completion date | October 30, 2019 |
Est. primary completion date | May 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 85 Years |
Eligibility |
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 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 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). |
Country | Name | City | State |
---|---|---|---|
Greece | Greek Alzheimer's Association and Related Disorders | Thessaloníki | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Aristotle University Of Thessaloniki |
Greece,
Tsolaki M, Karathanasi E, Lazarou I, Dovas K, Verykouki E, Karacostas A, Georgiadis K, Tsolaki A, Adam K, Kompatsiaris I, Sinakos Z. Efficacy and Safety of Crocus sativus L. in Patients with Mild Cognitive Impairment: One Year Single-Blind Randomized, wit — View Citation
Tzekaki EE, Tsolaki M, Pantazaki AA, Geromichalos G, Lazarou E, Kozori M, Sinakos Z. Administration of the extra virgin olive oil (EVOO) in mild cognitive impairment (MCI) patients as a therapy for preventing the progress to AD. Hell J Nucl Med. 2019 Sep-Dec;22 Suppl 2:181. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Weight in Kilograms | Changes in weight | baseline, 12 and 24 months | |
Other | Height in Meters | Changes in Height | baseline, 12 and 24 months | |
Primary | Neuropsychological Assessment- Measurements to Assess General Cognitive Function. | Changes in Mini-Mental State Examination (MMSE) score | baseline, 12 and 24 months | |
Primary | FUCAS-Measurements to Assess Daily Functionality | Changes in Functional cognitive assessment scale (FUCAS) score score scale:0-42,cut offs:<42 | baseline, 12 and 24 months | |
Primary | Letter & Category Fluency Test- Measurement to Assess Verbal Fluency and Learning | Changes in the Letter & Category Fluency Test | baseline, 12 and 24 months | |
Primary | CDR- Measurements to Assess General Cognitive Function | Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes) | baseline, 12 and 24 months | |
Primary | MoCA- Measurements to Assess General Cognitive Function | Changes in Montreal Cognitive Assessment (MoCA) | baseline, 12 and 24 months | |
Primary | Clock Drawing test- Measurements to Assess General Cognitive Function | Changes in the Clock Drawing test | baseline, 12 and 24 months | |
Primary | Logical Memory test- Measurements to Assess General Cognitive Function | Changes in the Logical Memory test | baseline, 12 and 24 months | |
Primary | Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function | Changes in the Digit Span Forward & Backward test | baseline, 12 and 24 months | |
Primary | WAIS-R Digit Symbol- Measurements to Assess General Cognitive Function | Changes in the WAIS-R Digit Symbol Substitution Test | baseline, 12 and 24 months | |
Primary | TMT part A and B- Measurements to Assess General Cognitive Function | Changes in the Trail Making Test | baseline, 12 and 24 months | |
Primary | ADASCog-Measurements to Assess Daily Functionality | Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog) | baseline, 12 and 24 months | |
Primary | Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality | Changes in Functional Rating Scale for Dementia (FRSSD) | baseline, 12 and 24 months | |
Primary | Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning | Changes in the Auditory Verbal Learning Test | baseline, 12 and 24 months | |
Secondary | NeuroImaging | Changes in brain Magnetic Resonance Imaging (MRI) 1.5 Tesla (brain atrophy) | baseline, 12 and 24 months | |
Secondary | CSF - beta amyloid | Changes in mean values on high sensitivity beta-amyloid 1-42 protein | baseline, 12 and 24 months | |
Secondary | CSF TAU-protein | Changes in mean values on TAU-protein in cerebrospinal fluid | baseline, 12 and 24 months | |
Secondary | Electroencephalography recording | Changes in Event-Related Potential (ERP) (oddball paradigm, auditory ERPs) Electroencephalography recording Changes in Electroencephalography (EEG), resting state. The device records brain signals through 57 electrodes, 2 reference electrodes attached to the earlobes, and a ground electrode placed at a left anterior position | baseline, 12 and 24 months |
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