Coenzyme Q10 for dementia

JRCT ID: jRCTs061180062

Registered date:18/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Dementia
• Date of first enrollment: 13/02/2017
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Positive drug: Taking of reduced Coenzyme Q10 (300mg,6 capsules) per oral once a day for 12 months
Placebo drug: Taking of placebo capsules (increased base,6 capsules) per oral once a day for 12 months

Outcome(s)

• Primary Outcome: Frequency of participants with change of ADAS-Jcog being less than zero after dose of reduced Coenzyme Q10 for 48 weeks

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: <= 89age old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: ABE SATOSHI
• Source(s) of Monetary Support: KANEKA corporation
• Secondary ID(s): UMIN000019587