Clinical study to evaluate the efficacy and safety of Ultra-Ma in patients diagnosed as having Lewy bodies dementia

Phase 2

• Conditions: Dementia with Lewy Bodies

• Registration Number: JPRN-jRCTs032190012
• Lead Sponsor: Manabe Yuta

Brief Summary

From improvement and change in NPI-Q severity, BPSD was confirmed a certain improvement. Zarit-8 improvements may have a certain effect on reducing the burden on caregivers. Improvement in MMSE indicated a certain improvement in cognitive function. The percentage change in UPDRSIII was significantly improved indicated the parkinsonian symptoms associated with dementia with Lewy bodies. The limited analysis suggested the usefulness of Ultra-Ma. A validation study should be conducted based on this study.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-17
• Study Completion: 2020-11-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Hachinski ischemic score <= 4 points
-CDR-J >= 0.5 points, with mild cognitive impairment and dementia
-MMSE score of 11 to 27 points
-1 point >= some of the items of NPI-Q
-Diagnosed as Probable DLB as per the clinical diagnostic criteria of Lewy body dementia (CDLB Guideline 2017)
-Home care patient who satisfy the following criteria. Has a family or caregiver who can always observe the condition. Receiving more than two thirds of nursing care by one parson.
-Ability to keep symptom diary by himself/herself or by a caregiver
-Either or both of the following treatment has been effective for four weeks or more before the study begins
1) Cholinesterase inhibitors
2) L-dopa preparations

Exclusion Criteria

-Active dementia other than Lewy body dementia
-Hachinski ischemic score >=5 points and suspected of vascular dementia complications through imaging findings of MRI or CT scan performed within a year before the consent (Focal brain lesions or multiple infarctions, known as the cause of dementia, are observed)
-Has any severe neuropsychiatric disorder complications such as cerebrovascular disorder, brain tumor, schizophrenia, epilepsy, normal-pressure hydrocephaly, mental retardation, head trauma with disturbed consciousness, history of brain surgery with residual defect, and so on.
-Has severe parkinsonian symptoms (Hoehn & Yahr severity category >= IV)
-Unable to perform MMSE and/or NPI-Q tests and so on (has visual and/or hearing impairment, and/or aphasia.
-Bedridden patient or inhabitants of an institution(health institution for elderly, rehabilitation facility for elderly, and so on )
-Use of any implantable medical electrical equipment, such as pacemaker and/or implantable defibrillation equipment, which are susceptible to the impact of electromagnetic interference
-Any metal components placed inside the skull (ex. indwelling coil)
-Use of any In-the-ear (ITE) hearing aid,cochlear implant,or middle ear implant.
-Has participated in other clinical research or clinical study for Lewy body dementia within a year before the time of consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified