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Effects of idebenone on cerebral glucose metabolism in patients with mild Alzheimer's disease: a twelve-week randomized, double-blind, placebo-controlled trial

Effects of idebenone on cerebral glucose metabolism in patients with mild Alzheimer's disease: a twelve-week randomized, double-blind, placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018478
Enrollment
Unknown
Registered
2018-09-20
Start date
2018-09-17
Completion date
Unknown
Last updated
2018-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's disease

Interventions

Group 1:idebenone
Group 2:placebo

Sponsors

The First Affiliated Hospital of Xi’an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged 50 to 85 years (including 50 and 85 years), regardless of sex; 2. Meeting the diagnostic criteria for AD by the NINCDS-ADRDA(1984); 3. Mild AD, i.e.the MMSE score 15-26 (score 15-22 for subjects with primary education); 4. The harzinski ischemia scale (HIS)score =4 ; 5. Memory loss for 12 or more months, with a trend of progressive aggravation; 6. Complete head MRI plan scan and oblique coronal scan for the hippocampus: number of cerebral infarcts larger than 2cm in diameter=2; no critical infarct site, such as infarcts located in the thalamus, hippocampus, entorhinal cortex, parolfactoria cortex, angular gyrus and other subcortical gray matter nuclei; fazekas Scale<2; lesions that showed by MRI are most likely to be diagnosed with AD (MTA-scale=2); 7. There are no obvious signs of nervous system examination; 8. Drugs that affect mitochondrial function such as Idebenone, Coenzyme Q10, Vitamin E and Butylphthalide were not used; 9. Participants who have primary school education or above and have the ability to complete the cognitive tests and other tests; 10. Sign the consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who have dementia caused by other factors: vascular dementia, central nervous system infections (HIV/Aids and syphilis), Parkinson's disease, Lewy body dementia, cerebral traumatic dementia, other physical and chemical factors (drug poisoning, alcoholism, carbon monoxide poisoning, etc.), intracranial space-occupying lesions (subdural hematoma, brain tumor, etc.), endocrine system diseases (thyroid diseases, parathyroid diseases, etc.), and dementia caused by vitamin deficiency or any other factors; 2. Patients who have suffered from nervous system diseases (including stroke, optic myelitis, Parkinson's disease, epilepsy, etc.); 3. Patients who have suffered from psychopath, according to the DSM-IV-TR standard, which includes schizophrenia or other mental disorders, bipolar disorder, severe depression or delirium; 4. Patients who have severe heart, respiratory, liver, kidney and hematopoietic system diseases; 5. Patients who have serious visual and/or hearing disorders effects of completing the neuropsychological tests and scales; 6. Patients who have used cholinesterase inhibitors, memantine, oxiracetam, etc.

Design outcomes

Primary

MeasureTime frame
cerebral metabolic rate of glucose;Aß40;sLRP1;sRAGE;SOD;MDA;Aß42;

Secondary

MeasureTime frame
MMSE;ADAS-cog;CIBIC-plus;NPI;ADL;

Countries

China

Contacts

Public ContactQiumin Qu

Tthe First Affiliated Hospital of Xi’an Jiaotong University

quqiumin@126.com+86 13892898562

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026