Management of Mild Cognitive Impairment Patients With Aloe and Crocus - BALSAM

NCT04436614 | Completed

• 1 other identifier: 31b/17-05-17
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment,; Aloe,; Crocus,; Intervention

Outcome Measures

Primary Outcomes (13)

• Neuropsychological Assessment- Measurements to Assess General Cognitive Function.

  Changes in Mini-Mental State Examination (MMSE) score

  baseline, 12 and 24 months

• 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

• Letter & Category Fluency Test- Measurement to Assess Verbal Fluency and Learning

  Changes in the Letter \& Category Fluency Test

  baseline, 12 and 24 months

• CDR- Measurements to Assess General Cognitive Function

  Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes)

  baseline, 12 and 24 months

• MoCA- Measurements to Assess General Cognitive Function

  Changes in Montreal Cognitive Assessment (MoCA)

  baseline, 12 and 24 months

• Clock Drawing test- Measurements to Assess General Cognitive Function

  Changes in the Clock Drawing test

  baseline, 12 and 24 months

• Logical Memory test- Measurements to Assess General Cognitive Function

  Changes in the Logical Memory test

  baseline, 12 and 24 months

• Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function

  Changes in the Digit Span Forward \& Backward test

  baseline, 12 and 24 months

• WAIS-R Digit Symbol- Measurements to Assess General Cognitive Function

  Changes in the WAIS-R Digit Symbol Substitution Test

  baseline, 12 and 24 months

• TMT part A and B- Measurements to Assess General Cognitive Function

  Changes in the Trail Making Test

  baseline, 12 and 24 months

• ADASCog-Measurements to Assess Daily Functionality

  Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog)

  baseline, 12 and 24 months

• Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality

  Changes in Functional Rating Scale for Dementia (FRSSD)

  baseline, 12 and 24 months

• Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning

  Changes in the Auditory Verbal Learning Test

  baseline, 12 and 24 months

Secondary Outcomes (4)

• NeuroImaging

  baseline, 12 and 24 months

• CSF - beta amyloid

  baseline, 12 and 24 months

• CSF TAU-protein

  baseline, 12 and 24 months

• Electroencephalography recording

  baseline, 12 and 24 months

Other Outcomes (2)

• Weight in Kilograms

  baseline, 12 and 24 months

• Height in Meters

  baseline, 12 and 24 months

Study Arms (3)

Aloe Vera and Crocus

EXPERIMENTAL

50 patients Aloe Vera and Crocus (saffron) 1L, 1 bottle per 15 days. Dietary Supplement: Aloe Vera and Crocus (saffron) in a glass bottle Intervention: Dietary Supplement: Aloe Vera and Crocus (saffron) in a glass bottle 1L, per 15 days.

Dietary Supplement: Dietary Supplement:Aloe Vera with Crocus (saffron)

Aloe Vera

PLACEBO COMPARATOR

50 patients Aloe Vera (simple) in a glass bottle 1L, 1 bottle per 15 days. Dietary Supplement: Aloe Vera (simple) in a glass bottle Intervention: Dietary Supplement: Aloe Vera (simple) in a glass bottle in a glass bottle 1L, per 15 days.

Dietary Supplement: Dietary Supplement:Aloe Vera (simple)

Mediterranean Diet

OTHER

50 patients Mediterranean dietary protocol Intervention:mediterranean diet

Dietary Supplement: Dietary Supplement:Mediterranean Diet

Interventions

Dietary Supplement:Aloe Vera with Crocus (saffron) DIETARY_SUPPLEMENT

Dietary Supplement:Aloe Vera with Crocus (saffron) with 1L of Aloe Vera with Crocus (saffron) 1 glass bottle per 15 days

Aloe Vera and Crocus

Dietary Supplement:Aloe Vera (simple) DIETARY_SUPPLEMENT

Dietary Supplement:Aloe Vera (simple)with 1L of Aloe Vera 1 glass bottle per 15 days

Aloe Vera

Dietary Supplement:Mediterranean Diet DIETARY_SUPPLEMENT

Dietary Supplement:Mediterranean dietary protocol Intervention:mediterranean diet

Mediterranean Diet

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Greek Alzheimer's Association and Related Disorders

Thessaloniki, Thessaloniki, 54248, Greece

Location

Related Publications (2)

• 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.

  PMID: 31802059 BACKGROUND

• 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.

  PMID: 27472878 RESULT

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor, President of Greek Alzheimer's Association and Related Disorders

Model Details: Single (Participant)

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: June 18, 2020
• Study Start: December 17, 2017
• Primary Completion: May 30, 2018
• Study Completion: October 30, 2019
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)