NCT06040905

Brief Summary

The aim of the study is to investigate the effect of coenzyme Q10 supplementation (150 mg/b.i.d, 300 mg/d, 12 weeks) on coenzyme Q10, glucose parameters, BDNF, myokines, and cognitive function in mild cognitive impairment (MCI) and Alzheimer's disease (AD) patients who combined with hyperglycemia but without sarcopenia, or with hyperglycemia and pre-sarcopenia.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Dec 2023Jul 2026

First Submitted

Initial submission to the registry

September 4, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

December 26, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

2.6 years

First QC Date

September 4, 2023

Last Update Submit

February 5, 2024

Conditions

Mild Cognitive ImpairmentAlzheimer DiseaseHyperglycemiaPre-sarcopenia

Outcome Measures

Primary Outcomes (7)

  • Fasting glucose

    Fasting glucose will measured by an automated chemistry analyzer.

    12 weeks

  • HbA1C

    HbA1C will measured by an automated glycated hemoglobin analyzer.

    12 weeks

  • Insulin

    Insulin will measured by chemiluminescence assay.

    12 weeks

  • C-peptide

    C-peptide will measured by chemiluminescence assay.

    12 weeks

  • Brain-derived neurotrophic factor (BDNF)

    Sreum BDNF level will measured by huamn BDNF ELISA kit.

    12 weeks

  • Irisin

    Measured by huamn Irisin ELISA kit.

    12 weeks

  • Myostatin

    Measured by human myostatin ELISA kit.

    12 weeks

Secondary Outcomes (7)

  • Malondialdehyde (MDA) level

    12 weeks

  • Advanced Glycation End Products (AGEs) level

    12 weeks

  • Total antioxidant capacity

    12 weeks

  • Mini-Mental State Examination (MMSE) score

    12 weeks

  • Muscle mass

    12 weeks

  • +2 more secondary outcomes

Other Outcomes (4)

  • ATP level

    12 weeks

  • Citrate synthase level

    12 weeks

  • Quality of Life in Alzheimer's Disease Measure (QOL-AD)

    12 weeks

  • +1 more other outcomes

Study Arms (2)

Coenzyme Q10

EXPERIMENTAL

Coenzyme Q10 300 mg/day (150 mg/b.i.d.)

Dietary Supplement: Coenzyme Q10

Placebo

PLACEBO COMPARATOR

Placebo (dextrin)

Other: Placebo

Interventions

Coenzyme Q10DIETARY_SUPPLEMENT

300 mg/day (150mg/b.i.d)

Coenzyme Q10
PlaceboOTHER

Starch, dextrin

Placebo

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of mild cognitive impairment (MCI).
  • Clinical diagnosis of Alzheimer's Disease.
  • MCI and AD patients with hyperglycemia ( Fasting glucose \>=100 mg/dL).
  • MCI and AD patients with pre-sarcopenia (low calf circumference, low hand grip, or low muscle endurance).
  • Must be able to swallow tablets.

You may not qualify if:

  • Cancer patients.
  • Severe heart, lung, liver, and kidney diseases.
  • Severe disability or aphasia.
  • Malnutrition (body weight changes \> 5% within one month).
  • Using coenzyme Q10 supplements.
  • Warfarin therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer DiseaseHyperglycemia

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ping-Ting Lin, Ph.D.

    Chung Shan Medical University

    STUDY DIRECTOR

Central Study Contacts

Ping-Ting Lin, Ph.D.

CONTACT

+886-4-24730022apt810@csmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 4, 2023

First Posted

September 18, 2023

Study Start

December 26, 2023

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

February 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)