Alzheimer DiseasePhase 2NCT03752463
NMDA Enhancer for the Treatment of Mild Alzheimer's Disease
A Phase 2 study testing DAOI-A group, DAOI-B group and DAOI-C group in people with Alzheimer Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
NMDA neurotransmission plays an important role in learning and memory. NMDA receptors (NMDAR) were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease (AD). This study is a randomized, double-blind, placebo controlled drug trial for testing the efficacy of NMDAR-enhancer. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- DAOI-A group, DAOI-B group and DAOI-C group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 May 2015to 31 Jul 2021
- Phase
- Phase 2
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Alzheimer's disease
- MMSE between 10-26
- CDR 1
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.
About this study
NMDA neurotransmission plays an important role in learning and memory. NMDA receptors (NMDAR) were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease (AD). This study is a randomized, double-blind, placebo controlled drug trial for testing the efficacy of NMDAR-enhancer. All subjects will be allocated randomly to 4 groups: (1) DAOI-A group; (2) DAOI-B group; (3) DAOI-C group; (4) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI may yield better efficacy than placebo for cognitive function in patients with AD.
- Conditions
- Alzheimer Disease
- Being tested
- DAOI-A group, DAOI-B group, DAOI-C group, Placebo oral capsule
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAOI-A groupDrug
DAOI with A dose
DAOI-B groupDrug
DAOI with B dose
DAOI-C groupDrug
DAOI with C dose
Placebo oral capsuleDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| DAOI-A group | Experimental | Not described Receives: Drug: DAOI-A group |
| DAOI-B group | Experimental | Not described Receives: Drug: DAOI-B group |
| DAOI-C group | Experimental | Not described Receives: Drug: DAOI-C group |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24
Cognitive assessment
Measured: week 0, 8, 16, 24
Secondary outcomes (4)
Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input at week 8, 16 and 24
Global assessment
Measured: week 8, 16, 24
Change from baseline in speed of processing (Category Fluency) at week 24
Cognitive assessment
Measured: week 0, 24
Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24
Cognitive assessment
Measured: week 0, 24
Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) at week 24
Cognitive assessment
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.
- First posted26 Nov 2018
- Study start22 May 2015
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752463
- Sponsor's protocol ID
- 105-3412C
- Status last verified
- Aug 2021
- First submitted
- 21 Nov 2018
- Last updated
- 26 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin CH, Lane HY. Sodium benzoate treatment decreased amyloid beta peptides and improved cognitive function among patients with Alzheimer's disease: secondary analysis of a randomized clinical trial. Transl Psychiatry. 2025 Aug 5;15(1):264. doi: 10.1038/s41398-025-03492-3.
PubMed 40764372Lane HY, Wang SH, Lin CH. Sex- and dose-dependent catalase increase and its clinical impact in a benzoate dose-finding, randomized, double-blind, placebo-controlled trial for Alzheimer's disease. Pharmacol Biochem Behav. 2024 Dec;245:173885. doi: 10.1016/j.pbb.2024.173885. Epub 2024 Oct 9.
PubMed 39384087
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NMDA Enhancer for the Treatment of Mild Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03752463
- Acronym / sponsor ID
- 105-3412C
- Conditions
- Alzheimer Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 22 May 2015 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 26 Nov 2018 (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.
NMDA neurotransmission plays an important role in learning and memory. NMDA receptors (NMDAR) were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease (AD). This study is a randomized, double-blind, placebo controlled drug trial for testing the efficacy of NMDAR-enhancer. All subjects will be allocated randomly to 4 groups: (1) DAOI-A group; (2) DAOI-B group; (3) DAOI-C group; (4) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI may yield better efficacy than placebo for cognitive function in patients with AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DAOI-A group | Experimental | Drug: DAOI-A group |
| DAOI-B group | Experimental | Drug: DAOI-B group |
| DAOI-C group | Experimental | Drug: DAOI-C group |
| Placebo group | Placebo comparator | Drug: Placebo oral capsule |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Alzheimer's disease
- MMSE between 10-26
- CDR 1
Key exclusion criteria (6 listed)
- Hachinski Ischemic Score > 4
- Substance abuse/dependence
- Parkinson disease, epilepsy, dementia with psychotic features
- Major depressive disorder
- Major physical illnesses
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 |
|---|---|---|
| DAOI-A groupDAOI with A dose | Drug | DAOI-A group |
| DAOI-B groupDAOI with B dose | Drug | DAOI-B group |
| DAOI-C groupDAOI with C dose | Drug | DAOI-C group |
| Placebo oral capsulePlacebo | Drug | Placebo group |
Primary outcome
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
Cognitive assessment
4 secondary outcomes
Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input at week 8, 16 and 24
Time frame: week 8, 16, 24
Change from baseline in speed of processing (Category Fluency) at week 24
Time frame: week 0, 24
Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24
Time frame: week 0, 24
Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) at week 24
Time frame: week 0, 24
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 26 Aug 2021.
- Derived from this study: PubMed 40764372Lin CH, Lane HY. Sodium benzoate treatment decreased amyloid beta peptides and improved cognitive function among patients with Alzheimer's disease: secondary analysis of a randomized clinical trial. Transl Psychiatry. 2025 Aug 5;15(1):264. doi: 10.1038/s41398-025-03492-3.
- Derived from this study: PubMed 39384087Lane HY, Wang SH, Lin CH. Sex- and dose-dependent catalase increase and its clinical impact in a benzoate dose-finding, randomized, double-blind, placebo-controlled trial for Alzheimer's disease. Pharmacol Biochem Behav. 2024 Dec;245:173885. doi: 10.1016/j.pbb.2024.173885. Epub 2024 Oct 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DAOI-A group, DAOI-B group and DAOI-C group in people with Alzheimer Disease, 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: finished, as of the sponsor's last update on 26 Aug 2021. 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?
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?
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 NCT03752463, which also lists 2 linked publications.
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 26 Aug 2021.