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Alzheimer DiseasePhase 2NCT06467539

Novel Augmentation of DAOIB and Antioxidant for Early Dementia

A Phase 2 study testing DAOIB plus AO in people with Alzheimer Disease and Mild Cognitive Impairment, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Previous studies found that some NMDA-enhancing agents were able to improve cognitive function of patients with early-phase dementia. In addition, several drugs with antioxidant properties have been tested in clinical trials for the treatment of dementia too. Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Alzheimer Disease, Mild Cognitive Impairment
What is being tested?
DAOIB plus AO
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteTaiwan
Study dates
19 Jun 2024to May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of Alzheimer's disease or mild cognitive impairment
  • MMSE between 10-26
  • CDR 1 or 0.5

Who cannot join

  • Hachinski Ischemic Score > 4
  • Substance abuse/dependence
  • Parkinson disease, epilepsy, dementia with psychotic features
  • Major depressive disorder
  • Major physical illnesses
  • Severe visual or hearing impairment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site, 1 recruiting

  • Chang Gung Memorial Hospital

    Kaohsiung City, 886

    Chieh-Hsin Lin, MD, PhD, 886-7-7317123 ext. 8753, cyndi36@gmail.com

    Chieh-Hsin Lin, MD, PhD

    Recruiting

Other trials in Taiwan

About this study

Previous studies found that some NMDA-enhancing agents were able to improve cognitive function of patients with early-phase dementia. In addition, several drugs with antioxidant properties have been tested in clinical trials for the treatment of dementia too. Whether combined treatment of an NMDA-enhancing agent and a drug with antioxidant property can be better than an NMDA-enhancing agent alone deserves study.

Being tested
DAOIB plus AO, DAOIB plus placebo
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DAOIB plus AODrug

    oral, for 24 weeks

  • DAOIB plus placeboDrug

    oral, for 24 weeks

Study groups in NCT06467539
Study groupRoleWhat they receive
ExperimentalExperimentalDAOIB plus Antioxidant agent (AO)
Receives: Drug: DAOIB plus AO
Placebo ComparatorPlacebo comparatorDAOIB plus Placebo
Receives: Drug: DAOIB plus placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24

    Alzheimer's disease assessment scale-cognitive subscale consists of 11 tasks. Its scores range from 0 (best) to 70 (worst).

    Measured: week 0, 8, 16, 24

Secondary outcomes (6)

  1. Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24

    Clinician's Interview-Based Impression of Change plus Caregiver Input score is a global assessment of change based on a comprehensive, semi-structured interview which includes caregiver-supplied information. It is a 7-point rating scale ranging from 1-7, where 1 represents markedly improved; 4, no change; and 7, markedly worse.

    Measured: week 8, 16, 24

  2. Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24

    Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24

    Measured: week 0, 8, 16, 24

  3. Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score at week 8, 16 and 24

    Clinical Dementia Rating Scale (CDR) is a global assessment tool that yields global and Sum of Boxes scores (SB). Compared to the global CDR score, the CDR-SB score provides better utility in tracking changes in dementia severity.

    Measured: week 0, 8, 16, 24

  4. Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24

    ADCS-MCI-ADL appears to be a suitable instrument for evaluating activities of daily living in mild cognitive impairment. Its scores range from 0 (worst) to 78 (best).

    Measured: week 0, 8, 16, 24

  5. Change from baseline in Medical Outcomes Study Short-Form-36 (SF-36) score at week 8, 16 and 24

    The SF-36 consists of eight sections which assess the quality of life.

    Measured: week 0, 8, 16, 24

  6. Change from baseline in the composite score of a battery of additional cognitive tests at week 8, 16 and 24

    The battery of additional cognitive tests include speed of processing (Category Fluency), working memory (verbal and nonverbal, Wechsler Memory Scale), learning and memory tests (verbal and visual, Wechsler Memory Scale).

    Measured: week 0, 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2024
  2. Study start19 Jun 2024
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06467539
Sponsor's protocol ID
202200458A3C502
Status last verified
Mar 2026
First submitted
16 Jun 2024
Last updated
19 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DAOIB plus AO in people with Alzheimer Disease and Mild Cognitive Impairment, run by Chang Gung Memorial Hospital 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 3 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: looking for participants now, as of the sponsor's last update on 19 Mar 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24 (time frame: week 0, 8, 16, 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06467539.

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 19 Mar 2026.

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