Status:
UNKNOWN
Management of Mild Cognitive Impairment Patients With Greek Mountain Tea - TEAMENTIA
Lead Sponsor:
Aristotle University Of Thessaloniki
Conditions:
Mild Cognitive Impairment
Eligibility:
All Genders
55-85 years
Phase:
NA
Brief Summary
There is accumulating evidence suggesting that Greek Mountain Tea may have a positive impact on conditions involving cognitive deficits, such as Mild Cognitive Impairment (MCI) and AD. More specifical...
Detailed Description
OBJECTIVES OF THE TRIAL The objectives of this study are: To investigate the efficacy of Greek Mountain Tea as a disease course modifying treatment for MCI in a phase III double-blind placebo-contro...
Eligibility Criteria
Inclusion
- Memory Complaints
- Abnormal memory function documented by scoring 1 SD below the ageadjusted 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
- 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).
Key Trial Info
Start Date :
November 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04435509
Start Date
November 17 2019
End Date
May 30 2021
Last Update
June 17 2020
Active Locations (1)
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1
Greek Alzheimer's Association and Related Disorders
Thessaloniki, Thessaloniki, Greece, 54248