Management of Dementia With Olive Oil Leaves - GOLDEN

NCT04440020 | Unknown

• 1 other identifier: ID: 46/6-2-19a
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Mild Dementia (Mild Dementia) is a state of mind disorder (memory, reason, attention, concentration, time orientation) with difficulty in the complex activities of everyday life (bank accounts, shopping, transportation, etc).The olive leaves contain several phenolic compounds, most important of which are oleo-European and hydroxytyrosol. The properties of the olive leaves have been attributed mainly to these two substances.

Conditions

Prevention

Keywords

olive oil tree; leaves; Mild Dementia; prevention; Alzheimer's disease

Outcome Measures

Primary Outcomes (13)

• Neuropsychological Assessment - Measurements to Assess General Cognitive Function

  Changes in Mini-Mental State Examination (MMSE) score Score scale:0-30,cut off:24

  baseline,24 months

• FUCAS-Measurements to Assess Daily Functionality

  Changes in Functional cognitive assessment scale (FUCAS) score Score scale:42-126,cut off:42

  baseline,24 months

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

  Changes in the Letter \& Category Fluency Test

  baseline,24 months

• CDR- Measurements to Assess General Cognitive Function

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

  baseline,24 months

• MoCA- Measurements to Assess General Cognitive Function

  Changes in Montreal Cognitive Assessment (MoCA)

  baseline,24 months

• Clock Drawing test- Measurements to Assess General Cognitive Function

  Changes in the Clock Drawing test

  baseline,24 months

• Logical Memory test- Measurements to Assess General Cognitive Function

  Changes in the Logical Memory test

  baseline, 24 months

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

  Changes in the Digit Span Forward \& Backward test

  baseline,24 months

• WAIS-R (Wechler Adult Intelligence scele) Digit Symbol- Measurements to Assess General Cognitive Function

  Changes in the WAIS-R Digit Symbol Substitution Test

  baseline,24 months

• TMT(Trail Making Test) part A and B- Measurements to Assess General Cognitive Function

  Changes in the Trail Making Test

  baseline, 24 months

• ADASCog-Measurements to Assess Daily Functionality

  Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog) Score scale:0-70,cut off:\<15

  baseline, 24 months

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

  Changes in Functional Rating Scale for Dementia (FRSSD) Score scale:0-6,cut off:\>6

  baseline, 24 months

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

  Changes in the Auditory Verbal Learning Test

  baseline,24 months

Secondary Outcomes (4)

• NeuroImaging

  baseline,24 months

• CSF - beta amyloid

  baseline,24 months

• CSF(cerebrospinal fluid) TAU-protein ( soluble protein)

  baseline,24 months

• Electroencephalography recording

  baseline,24 months

Other Outcomes (2)

• Weight in Kilograms

  baseline,24 months

• Height in Meters

  baseline,24 months

Study Arms (2)

Beverage of Olive Oil Leaves

EXPERIMENTAL

50 patients Beverage of Olive Oil Leaves

Other: Beverage of Olive Oil Leaves

Mediterranean dietary protocol Intervention

ACTIVE COMPARATOR

50 patients Dietary Supplement: Dietary Supplement:Mediterranean Diet

Other: Mediterranean Diet

Interventions

Beverage of Olive Oil Leaves OTHER

Beverage of Olive Oil Leaves,Oleuropein

Beverage of Olive Oil Leaves

Mediterranean Diet OTHER

Mediterranean Diet ,for a personal nutrition with the same dietary habits

Mediterranean dietary protocol Intervention

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 18-24
• CDR(sum of boxes) \>= 0,5
• Diagnosis: Mild Dementia (Alzheimer's Dementia)
• 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 Associoation of Alzheimer'S Disease and Related Disorders

Thessaloniki, 54248, Greece

Location

Related Publications (2)

• 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

• 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 RESULT

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

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

Model Details: Single Participant

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 19, 2020
• Study Start: January 5, 2019
• Primary Completion: January 10, 2021
• Study Completion: April 10, 2021
• Last Updated: June 19, 2020

Record last verified: 2020-06

Locations

GR (1)