Coenzyme Q10 for dementia

Phase 3

Active, not recruiting

Conditions: Dementia

Registration Number: JPRN-jRCTs061180062

Lead Sponsor: ABE SATOSHI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

1)Diagnosis is one of five types of dementia.
Alzheimer disease, Vascular dementia, Dementia of Lewy Body, frontotemporal dementia, Mild Cognitive Impairment: (MCI)
2)Clinical Dementia Rating (CDR) is 0.5,1 or 2 (mild-moderate dementia).
3)Mini-Mental State Examination (MMSE) score is between 15 and 28.
4)Treatment has been kept with four drugs, donepezil, galantamine, rivastigmine, memantine and some other drug.
5)Agreement with clinical trial is between 50 and 89 years old.
6)A declaration of consent shall be valid if drawn up as a document providing sufficient evidence.

Exclusion Criteria

1)Metabolic encephalopathy (hypothyroidism, Vitamin B12 deficiency)
2)Post head trauma
3)Delirium due to any drugs
4)Alcohol abuse
5)Depression under medication
6)Mental disorder treated by antipsychotic drugs
7)Schizophrenia, mania, severe heart failure, and severe liver injury.
8)Chronic renal failure with creatinine clearance less than 20 ml/min.
9)Treated with malignancy
10) Investigator decides inappropriate for enrollment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of participants with change of ADAS-Jcog being less than zero after dose of reduced Coenzyme Q10 for 48 weeks

Secondary Outcome Measures

Name	Time	Method
1)Change of ADAS-Jcog post 48 weeks dose of reduced Coenzyme Q10<br>2)Rate of clinically effective cases<br>3)Changes of neural network on functional MRI<br>4)Adverse event (frequency and degree of severity)<br>5)Comparison with choline esterase inhibitors and memantine