Mild Cognitive ImpairmentNCT06040905
Causal Effect of Coenzyme Q10 Nutrition and Cognitive Dysfunction in the Metabolic Storm (Hyperglycemia and Sarcopenia) and Brain-derived Neurotrophic Factor
A study testing Coenzyme Q10 in people with Mild Cognitive Impairment and Alzheimer Disease, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
The aim of the study is to investigate the effects of coenzyme Q10 supplementation (150 mg twice daily; 300 mg/day for 12 weeks) on coenzyme Q10 status, glucose parameters, BDNF, myokines, and cognitive function in patients with mild cognitive impairment (MCI) or Alzheimer's disease (AD) and hyperglycemia, either… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease, Hyperglycemia
- What is being tested?
- Coenzyme Q10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Jan 2024to 12 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of mild cognitive impairment (MCI) or Alzheimer's disease (AD).
- Hyperglycemia, defined as fasting plasma glucose ≥100 mg/dL or current use of glucose-lowering medication.
- Either without sarcopenia risk or with pre-sarcopenia/sarcopenia risk, as determined by calf circumference, handgrip strength, or muscle endurance.
- Ability to swallow tablets.
Who cannot join
- Cancer.
- Severe cardiac, pulmonary, hepatic, or renal disease.
- Severe disability or aphasia.
- Malnutrition (body weight change >5% within one month).
- Current use of coenzyme Q10 supplements.
- Current warfarin therapy.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to investigate the effects of coenzyme Q10 supplementation (150 mg twice daily; 300 mg/day for 12 weeks) on coenzyme Q10 status, glucose parameters, BDNF, myokines, and cognitive function in patients with mild cognitive impairment (MCI) or Alzheimer's disease (AD) and hyperglycemia, either without sarcopenia risk or with pre-sarcopenia/sarcopenia risk.
Read the detailed description
Mild cognitive impairment (MCI) and Alzheimer's disease (AD) are associated with impaired glucose and energy metabolism, oxidative stress, and nutritional imbalance. Coenzyme Q10 is an antioxidant nutrient involved in mitochondrial energy production and may have beneficial effects on glucose metabolism and muscle function. This randomized, double-blind, placebo-controlled crossover study investigated the effects of coenzyme Q10 supplementation in participants with MCI or AD and hyperglycemia, either without sarcopenia risk or with pre-sarcopenia/sarcopenia risk. Participants received coenzyme Q10 300 mg/day (150 mg twice daily) or placebo for 12 weeks, followed by a 4-week washout period and crossover to the alternate intervention for another 12 weeks. Anthropometric measurements, nutritional status, body composition, muscle function, cognitive function, quality of life, and depressive symptoms were assessed. Blood samples were collected to evaluate coenzyme Q10, glucose metabolism, BDNF, oxidative stress, antioxidant capacity, myokines, and mitochondrial function. The study aimed to evaluate the effects of coenzyme Q10 supplementation on glucose metabolism, muscle and physical function, and related metabolic and neurotrophic factors in participants with cognitive impairment and hyperglycemia.
- Being tested
- Coenzyme Q10, Placebo
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10Dietary supplement
300 mg/day (150 mg/b.i.d)
PlaceboOther
Starch
| Study group | Role | What they receive |
|---|---|---|
| Coenzyme Q10 followed by Placebo | Experimental | Participants received coenzyme Q10 300 mg/day (150 mg twice daily) for 12 weeks, followed by a 4-week washout period, and then placebo for 12 weeks. Receives: Dietary Supplement: Coenzyme Q10; Other: Placebo |
| Placebo followed by Coenzyme Q10 | Experimental | Participants received placebo for 12 weeks, followed by a 4-week washout period, and then coenzyme Q10 300 mg/day (150 mg twice daily) for 12 weeks. Receives: Dietary Supplement: Coenzyme Q10; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting glucose
Fasting glucose will be measured by an automated chemistry analyzer.
Measured: Baseline and at the end of each 12-week intervention period
HbA1C
HbA1C will be measured by an automated glycated hemoglobin analyzer.
Measured: Baseline and at the end of each 12-week intervention period
Insulin
Insulin will be measured by chemiluminescence assay.
Measured: Baseline and at the end of each 12-week intervention period
C-peptide
C-peptide will be measured by chemiluminescence assay.
Measured: Baseline and at the end of each 12-week intervention period
Brain-derived neurotrophic factor (BDNF)
Serum BDNF levels will be measured using a human BDNF ELISA kit.
Measured: Baseline and at the end of each 12-week intervention period
Irisin
Irisin levels will be measured using a human irisin ELISA kit.
Measured: Baseline and at the end of each 12-week intervention period
Secondary outcomes (8)
Advanced Glycation End Product (AGE) levels
AGE levels will be measured using a competitive enzyme-linked immunosorbent assay.
Measured: Baseline and at the end of each 12-week intervention period
Total antioxidant capacity
Total antioxidant capacity will be measured using a Trolox equivalent antioxidant capacity assay.
Measured: Baseline and at the end of each 12-week intervention period
Mini-Mental State Examination (MMSE) score
The MMSE score ranges from 0 to 30, with higher scores indicating better cognitive function.
Measured: Baseline and at the end of each 12-week intervention period
Muscle mass
Muscle mass will be measured using bioelectrical impedance analysis (BIA).
Measured: Baseline and at the end of each 12-week intervention period
Handgrip strength
Hand grip strength will be measured with a grip dynamometer.
Measured: Baseline and at the end of each 12-week intervention period
Short Physical Performance Battery (SPPB) score
SPPB is an objective measurement instrument of balance, lower extremity strength, and functional capacity.
Measured: Baseline and at the end of each 12-week intervention period
Protein carbonyl levels
Protein carbonyl levels will be measured using a colorimetric assay kit.
Measured: Baseline and at the end of each 12-week intervention period
Serotonin levels
Serotonin levels will be measured using an ELISA kit.
Measured: Baseline and at the end of each 12-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start24 Jan 2024
- Primary completion12 Feb 2026
- Study completion12 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council
- Responsible party
- Principal investigator, Ping-Ting Lin, Chung Shan Medical University
- Investigators
- Ping-Ting Lin, Ph.D., Study director, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040905
- Sponsor's protocol ID
- CS1-22182
- Status last verified
- Aug 2026
- First submitted
- 4 Sep 2023
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causal Effect of Coenzyme Q10 Nutrition and Cognitive Dysfunction in the Metabolic Storm (Hyperglycemia and Sarcopenia) and Brain-derived Neurotrophic Factor
- ClinicalTrials.gov ID
- NCT06040905
- Acronym / sponsor ID
- CS1-22182
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Collaborators
- National Science and Technology Council
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate the effects of coenzyme Q10 supplementation (150 mg twice daily; 300 mg/day for 12 weeks) on coenzyme Q10 status, glucose parameters, BDNF, myokines, and cognitive function in patients with mild cognitive impairment (MCI) or Alzheimer's disease (AD) and hyperglycemia, either without sarcopenia risk or with pre-sarcopenia/sarcopenia risk.
Detailed description
Mild cognitive impairment (MCI) and Alzheimer's disease (AD) are associated with impaired glucose and energy metabolism, oxidative stress, and nutritional imbalance. Coenzyme Q10 is an antioxidant nutrient involved in mitochondrial energy production and may have beneficial effects on glucose metabolism and muscle function. This randomized, double-blind, placebo-controlled crossover study investigated the effects of coenzyme Q10 supplementation in participants with MCI or AD and hyperglycemia, either without sarcopenia risk or with pre-sarcopenia/sarcopenia risk. Participants received coenzyme Q10 300 mg/day (150 mg twice daily) or placebo for 12 weeks, followed by a 4-week washout period and crossover to the alternate intervention for another 12 weeks. Anthropometric measurements, nutritional status, body composition, muscle function, cognitive function, quality of life, and depressive symptoms were assessed. Blood samples were collected to evaluate coenzyme Q10, glucose metabolism, BDNF, oxidative stress, antioxidant capacity, myokines, and mitochondrial function. The study aimed to evaluate the effects of coenzyme Q10 supplementation on glucose metabolism, muscle and physical function, and related metabolic and neurotrophic factors in participants with cognitive impairment and hyperglycemia.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coenzyme Q10 followed by Placebo | Experimental | Dietary Supplement: Coenzyme Q10, Other: PlaceboParticipants received coenzyme Q10 300 mg/day (150 mg twice daily) for 12 weeks, followed by a 4-week washout period, and then placebo for 12 weeks. |
| Placebo followed by Coenzyme Q10 | Experimental | Dietary Supplement: Coenzyme Q10, Other: PlaceboParticipants received placebo for 12 weeks, followed by a 4-week washout period, and then coenzyme Q10 300 mg/day (150 mg twice daily) for 12 weeks. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of mild cognitive impairment (MCI) or Alzheimer's disease (AD).
- Hyperglycemia, defined as fasting plasma glucose ≥100 mg/dL or current use of glucose-lowering medication.
- Either without sarcopenia risk or with pre-sarcopenia/sarcopenia risk, as determined by calf circumference, handgrip strength, or muscle endurance.
- Ability to swallow tablets.
Key exclusion criteria (6 listed)
- Cancer.
- Severe cardiac, pulmonary, hepatic, or renal disease.
- Severe disability or aphasia.
- Malnutrition (body weight change >5% within one month).
- Current use of coenzyme Q10 supplements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme Q10300 mg/day (150 mg/b.i.d) | Dietary supplement | Coenzyme Q10 followed by Placebo, Placebo followed by Coenzyme Q10 |
| PlaceboStarch | Other | Coenzyme Q10 followed by Placebo, Placebo followed by Coenzyme Q10 |
Primary outcome
Fasting glucose
Time frame: Baseline and at the end of each 12-week intervention period
Fasting glucose will be measured by an automated chemistry analyzer.
HbA1C
Time frame: Baseline and at the end of each 12-week intervention period
HbA1C will be measured by an automated glycated hemoglobin analyzer.
Insulin
Time frame: Baseline and at the end of each 12-week intervention period
Insulin will be measured by chemiluminescence assay.
C-peptide
Time frame: Baseline and at the end of each 12-week intervention period
C-peptide will be measured by chemiluminescence assay.
Brain-derived neurotrophic factor (BDNF)
Time frame: Baseline and at the end of each 12-week intervention period
Serum BDNF levels will be measured using a human BDNF ELISA kit.
Irisin
Time frame: Baseline and at the end of each 12-week intervention period
Irisin levels will be measured using a human irisin ELISA kit.
8 secondary outcomes
Advanced Glycation End Product (AGE) levels
Time frame: Baseline and at the end of each 12-week intervention period
Total antioxidant capacity
Time frame: Baseline and at the end of each 12-week intervention period
Mini-Mental State Examination (MMSE) score
Time frame: Baseline and at the end of each 12-week intervention period
Muscle mass
Time frame: Baseline and at the end of each 12-week intervention period
Handgrip strength
Time frame: Baseline and at the end of each 12-week intervention period
Short Physical Performance Battery (SPPB) score
Time frame: Baseline and at the end of each 12-week intervention period
Protein carbonyl levels
Time frame: Baseline and at the end of each 12-week intervention period
Serotonin levels
Time frame: Baseline and at the end of each 12-week intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping-Ting Lin, Ph.D. study director
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coenzyme Q10 in people with Mild Cognitive Impairment and Alzheimer Disease, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting glucose (time frame: Baseline and at the end of each 12-week intervention period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.