Mild Cognitive ImpairmentBALSAMNCT04436614
Management of Mild Cognitive Impairment Patients With Aloe and Crocus - BALSAM
A study testing Dietary Supplement:Aloe Vera with Crocus (saffron), Dietary Supplement:Aloe Vera (simple) and Dietary Supplement:Mediterranean Diet in people with Mild Cognitive Impairment, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Dietary Supplement:Aloe Vera with Crocus (saffron), Dietary Supplement:Aloe Vera (simple) and Dietary Supplement:Mediterranean Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 17 Dec 2017to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- Hachinski Modified Ischemic scale <= 4
- Stability of Permitted Medications for 4 weeks
- Years of education: >= 5
- Proficient language fluency
- Compliance
Who cannot join
- 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:
Show all 12Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Greece1 site
Greek Alzheimer's Association and Related Disorders
Thessaloniki, Thessaloniki, 54248
About this study
Official title: Randomized, Double Blind, Placebo Controlled Prospective Study, to Evaluate the Effect of Aloe Vera and Crocus in Patiens With Mild Cognitive Impairment
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
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Dietary Supplement:Aloe Vera with Crocus (saffron), Dietary Supplement:Aloe Vera (simple), Dietary Supplement:Mediterranean Diet
- Keywords
- Mild Cognitive Impairment,, Aloe,, Crocus,, Intervention
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Dietary Supplement:Aloe Vera (simple)Dietary supplement
Dietary Supplement:Aloe Vera (simple)with 1L of Aloe Vera 1 glass bottle per 15 days
Dietary Supplement:Mediterranean DietDietary supplement
Dietary Supplement:Mediterranean dietary protocol Intervention:mediterranean diet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Dietary Supplement:Aloe Vera (simple) |
| Mediterranean Diet | Other | 50 patients Mediterranean dietary protocol Intervention:mediterranean diet Receives: Dietary Supplement: Dietary Supplement:Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological Assessment- Measurements to Assess General Cognitive Function.
Changes in Mini-Mental State Examination (MMSE) score
Measured: 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
Measured: baseline, 12 and 24 months
Letter & Category Fluency Test- Measurement to Assess Verbal Fluency and Learning
Changes in the Letter \& Category Fluency Test
Measured: baseline, 12 and 24 months
CDR- Measurements to Assess General Cognitive Function
Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes)
Measured: baseline, 12 and 24 months
MoCA- Measurements to Assess General Cognitive Function
Changes in Montreal Cognitive Assessment (MoCA)
Measured: baseline, 12 and 24 months
Clock Drawing test- Measurements to Assess General Cognitive Function
Changes in the Clock Drawing test
Measured: baseline, 12 and 24 months
Logical Memory test- Measurements to Assess General Cognitive Function
Changes in the Logical Memory test
Measured: baseline, 12 and 24 months
Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function
Changes in the Digit Span Forward \& Backward test
Measured: baseline, 12 and 24 months
WAIS-R Digit Symbol- Measurements to Assess General Cognitive Function
Changes in the WAIS-R Digit Symbol Substitution Test
Measured: baseline, 12 and 24 months
TMT part A and B- Measurements to Assess General Cognitive Function
Changes in the Trail Making Test
Measured: baseline, 12 and 24 months
ADASCog-Measurements to Assess Daily Functionality
Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog)
Measured: baseline, 12 and 24 months
Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality
Changes in Functional Rating Scale for Dementia (FRSSD)
Measured: baseline, 12 and 24 months
Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning
Changes in the Auditory Verbal Learning Test
Measured: baseline, 12 and 24 months
Secondary outcomes (4)
NeuroImaging
Changes in brain Magnetic Resonance Imaging (MRI) 1.5 Tesla (brain atrophy)
Measured: baseline, 12 and 24 months
CSF - beta amyloid
Changes in mean values on high sensitivity beta-amyloid 1-42 protein
Measured: baseline, 12 and 24 months
CSF TAU-protein
Changes in mean values on TAU-protein in cerebrospinal fluid
Measured: baseline, 12 and 24 months
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
Measured: baseline, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start17 Dec 2017
- Primary completion30 May 2018
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single (Participant)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magda Tsolaki, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436614
- Sponsor's protocol ID
- 31b/17-05-17
- Acronym
- BALSAM
- Status last verified
- Jun 2020
- First submitted
- 24 Sep 2019
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31802059Tsolaki 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.
PubMed 27472878
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo Controlled Prospective Study, to Evaluate the Effect of Aloe Vera and Crocus in Patiens With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04436614
- Acronym / sponsor ID
- BALSAM / 31b/17-05-17
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment,, Aloe,, Crocus,, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 17 Dec 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Single (Participant)
| Arm | Type | Receives |
|---|---|---|
| Aloe Vera and Crocus | Experimental | Dietary Supplement: Dietary Supplement:Aloe Vera with Crocus (saffron)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. |
| Aloe Vera | Placebo comparator | Dietary Supplement: Dietary Supplement:Aloe Vera (simple)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. |
| Mediterranean Diet | Other | Dietary Supplement: Dietary Supplement:Mediterranean Diet50 patients Mediterranean dietary protocol Intervention:mediterranean diet |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Supplement:Aloe Vera with Crocus (saffron)Dietary Supplement:Aloe Vera with Crocus (saffron) with 1L of Aloe Vera with Crocus (saffron) 1 glass bottle per 15 days | Dietary supplement | Aloe Vera and Crocus |
| Dietary Supplement:Aloe Vera (simple)Dietary Supplement:Aloe Vera (simple)with 1L of Aloe Vera 1 glass bottle per 15 days | Dietary supplement | Aloe Vera |
| Dietary Supplement:Mediterranean DietDietary Supplement:Mediterranean dietary protocol Intervention:mediterranean diet | Dietary supplement | Mediterranean Diet |
Primary outcome
Neuropsychological Assessment- Measurements to Assess General Cognitive Function.
Time frame: baseline, 12 and 24 months
Changes in Mini-Mental State Examination (MMSE) score
FUCAS-Measurements to Assess Daily Functionality
Time frame: baseline, 12 and 24 months
Changes in Functional cognitive assessment scale (FUCAS) score score scale:0-42,cut offs:<42
Letter & Category Fluency Test- Measurement to Assess Verbal Fluency and Learning
Time frame: baseline, 12 and 24 months
Changes in the Letter \& Category Fluency Test
CDR- Measurements to Assess General Cognitive Function
Time frame: baseline, 12 and 24 months
Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes)
MoCA- Measurements to Assess General Cognitive Function
Time frame: baseline, 12 and 24 months
Changes in Montreal Cognitive Assessment (MoCA)
Clock Drawing test- Measurements to Assess General Cognitive Function
Time frame: baseline, 12 and 24 months
Changes in the Clock Drawing test
Logical Memory test- Measurements to Assess General Cognitive Function
Time frame: baseline, 12 and 24 months
Changes in the Logical Memory test
Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function
Time frame: baseline, 12 and 24 months
Changes in the Digit Span Forward \& Backward test
WAIS-R Digit Symbol- Measurements to Assess General Cognitive Function
Time frame: baseline, 12 and 24 months
Changes in the WAIS-R Digit Symbol Substitution Test
TMT part A and B- Measurements to Assess General Cognitive Function
Time frame: baseline, 12 and 24 months
Changes in the Trail Making Test
ADASCog-Measurements to Assess Daily Functionality
Time frame: baseline, 12 and 24 months
Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog)
Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality
Time frame: baseline, 12 and 24 months
Changes in Functional Rating Scale for Dementia (FRSSD)
Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning
Time frame: baseline, 12 and 24 months
Changes in the Auditory Verbal Learning Test
4 secondary outcomes
NeuroImaging
Time frame: baseline, 12 and 24 months
CSF - beta amyloid
Time frame: baseline, 12 and 24 months
CSF TAU-protein
Time frame: baseline, 12 and 24 months
Electroencephalography recording
Time frame: baseline, 12 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Background: PubMed 31802059Tzekaki 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.
- Results publication: PubMed 27472878Tsolaki 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.
- Individual participant dataSharing planned: No
Related trials for Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement:Aloe Vera with Crocus (saffron), Dietary Supplement:Aloe Vera (simple) and Dietary Supplement:Mediterranean Diet in people with Mild Cognitive Impairment, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological Assessment- Measurements to Assess General Cognitive Function. (time frame: baseline, 12 and 24 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04436614, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.