Clinical trial NCT04436614: Management of Mild Cognitive Impairment Patients With Aloe and Crocus - BALSAM
Official title: Randomized, Double Blind, Placebo Controlled Prospective Study, to Evaluate the Effect of Aloe Vera and Crocus in Patiens With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment,
Aloe,
Crocus,
Intervention
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single (Participant)
Primary purpose: TREATMENT

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. 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

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-controlled study.

To investigate the effects in objective measurements in patients with MCI.

STUDY DESIGN This is a Greek, randomised, double-blind, placebo-controlled study group of compared Aloe Vera and Crocus with placebo. Qualifying patients will be randomly assigned to receive 45 mL of Aloe Vera and Crocus or placebo (ALOE) or mediterranean dietary protocol on a daily basis for 24 months. Patients undergo assessments at baseline,12 and 24 months +/- 7 days after beginning of the treatment.

Duration The total study duration will be 36 months. Patients will receive study medication for 24 months.The recruitment will be about 6 months and the statistics and the preparation of the paper other 6 months.

Number of Subjects One hundred fifty (150) subjects total will be enrolled. ; Fifty (50) in the experimental group (Aloe Vera with Crocus); Fifty (50) in the Control Group 1(Aloe) and fifty (50) in control Group 2(same dietary habits-mediterranean dietary protocol).

Patient Eligibility Screening Form (ESF)

An eligibility form documenting the patient's fulfilment of the entry criteria will be completed by the assessor. The following information will be included in the ESF:

Patient identification: Initials (First initial of first name and First initial of surname), date of birth and Patient Identification Number.

Eligibility Screening; Checklist of inclusion and exclusion criteria Eligibility Statement; for patients found to be ineligible, the reason for ineligibility must be stated Written informed consent will be obtained from the subject . The informed consent form must be co-signed by the physician. The nature of the study and the potential risks associated with the trial will be explained to all subject candidates and their responsible informants.

Signature and date: the ESF may be completed by an assessor but it is required that the principal investigator/study clinician sign and date the ESF to verify eligibility of the patient for inclusion.

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 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).

Primary outcomes:
measure: Neuropsychological Assessment- Measurements to Assess General Cognitive Function.
timeFrame: baseline, 12 and 24 months
measure: FUCAS-Measurements to Assess Daily Functionality
timeFrame: baseline, 12 and 24 months
measure: Letter & Category Fluency Test- Measurement to Assess Verbal Fluency and Learning
timeFrame: baseline, 12 and 24 months
measure: CDR- Measurements to Assess General Cognitive Function
timeFrame: baseline, 12 and 24 months
measure: MoCA- Measurements to Assess General Cognitive Function
timeFrame: baseline, 12 and 24 months
measure: Clock Drawing test- Measurements to Assess General Cognitive Function
timeFrame: baseline, 12 and 24 months
measure: Logical Memory test- Measurements to Assess General Cognitive Function
timeFrame: baseline, 12 and 24 months
measure: Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function
timeFrame: baseline, 12 and 24 months
measure: WAIS-R Digit Symbol- Measurements to Assess General Cognitive Function
timeFrame: baseline, 12 and 24 months
measure: TMT part A and B- Measurements to Assess General Cognitive Function
timeFrame: baseline, 12 and 24 months
measure: ADASCog-Measurements to Assess Daily Functionality
timeFrame: baseline, 12 and 24 months
measure: Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality
timeFrame: baseline, 12 and 24 months
measure: Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning
timeFrame: baseline, 12 and 24 months
Secondary outcomes:
measure: NeuroImaging
timeFrame: baseline, 12 and 24 months
measure: CSF - beta amyloid
timeFrame: baseline, 12 and 24 months
measure: CSF TAU-protein
timeFrame: baseline, 12 and 24 months
measure: Electroencephalography recording
timeFrame: baseline, 12 and 24 months
Other outcomes:
measure: Weight in Kilograms
timeFrame: baseline, 12 and 24 months
measure: Height in Meters
timeFrame: baseline, 12 and 24 months
Locations:
city: Thessaloníki
country: Greece
facility: Greek Alzheimer's Association and Related Disorders
state: Thessaloniki
Study officials:
References:
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.
citation: 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, with Parallel Groups, Clinical Trial. J Alzheimers Dis. 2016 Jul 27;54(1):129-33. doi: 10.3233/JAD-160304.