Alzheimer's DiseasePhase 2NCT01600469
NMDA-enhancing Agent for Treatment of Mild Cognitive Impairment and Mild Alzheimer's Disease
A Phase 2 study testing DAOI-B in people with Alzheimer's Disease and Mild Cognitive Impairment, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
NMDA activation plays an important role in learning and memory. NMDA receptors were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease and mild cognitive function impairment. This study is a randomized, double-blind, placebo-controlled drug trial. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer's Disease, Mild Cognitive Impairment
- What is being tested?
- DAOI-B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2012to May 2013
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of mild cognitive impairment or mild Alzheimer's
- MMSE between 17-26
- CDR 0.5 or 1
Who cannot join
- Hachinski Ischemic Score > 4
- substance abuse/dependence
- Parkinson disease
- epilepsy
- major depressive disorder
- dementia with psychotic features
- major physical illnesses
- severe visual or hearing impairment
Trial locations and contacts
1 site in 1 country.
About this study
NMDA activation plays an important role in learning and memory. NMDA receptors were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease and mild cognitive function impairment. This study is a randomized, double-blind, placebo-controlled drug trial. All patients will be allocated randomly to 2 groups: (1) NMDA enhancer: DAOI-B group (starting dose: 250-500 mg/d); (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI-B may yield better efficacy than placebo for cognitive function in patients with mild cognitive impairment or mild Alzheimer's disease.
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment
- Being tested
- DAOI-B, Placebo
- Keywords
- Alzheimer's disease, mild cognitive impairment, NMDA
- 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.
DAOI-BDrug
250-1500 mg/day, oral, for 24 weeks
PlaceboOther
placebo, oral, for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| DAOI-B | Experimental | Not described Receives: Drug: DAOI-B |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Alzheimer's disease assessment scale-cognitive subscale in week 8, 16 and 24
Measured: Week 0, 8, 16, 24
Secondary outcomes (4)
Change from baseline in Mini Mental Status Examination at week 8, 16 and 24
Measured: Week 0, 8, 16, 24
Change from baseline in Instrumental Activities of Daily Living at week 8, 16 and 24
Measured: Week 0, 8, 16, 24
Change from baseline in Verbal learning and memory at week 24
Measured: Week 0, 24
Change from baseline in Digit Span subtest of the Wechsler Memory Scale at week 24
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 posted17 May 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsien-yuan Lane, MD, PhD, Study chair, Departments of Psychiatry, China Medical University Hospital, Taichung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600469
- Sponsor's protocol ID
- 99-2452A3
- Status last verified
- Apr 2011
- First submitted
- 14 May 2012
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NMDA-enhancing Agent for Treatment of Mild Cognitive Impairment and Mild Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01600469
- Acronym / sponsor ID
- 99-2452A3
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment
- Keywords
- Alzheimer's disease, mild cognitive impairment, NMDA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 17 May 2012 (estimated)
- 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 activation plays an important role in learning and memory. NMDA receptors were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease and mild cognitive function impairment. This study is a randomized, double-blind, placebo-controlled drug trial. All patients will be allocated randomly to 2 groups: (1) NMDA enhancer: DAOI-B group (starting dose: 250-500 mg/d); (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI-B may yield better efficacy than placebo for cognitive function in patients with mild cognitive impairment or mild Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAOI-B | Experimental | Drug: DAOI-B |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of mild cognitive impairment or mild Alzheimer's
- MMSE between 17-26
- CDR 0.5 or 1
Key exclusion criteria (8 listed)
- Hachinski Ischemic Score > 4
- substance abuse/dependence
- Parkinson disease
- epilepsy
- major depressive disorder
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-B250-1500 mg/day, oral, for 24 weeks | Drug | DAOI-B |
| Placeboplacebo, oral, for 24 weeks | Other | Placebo |
Primary outcome
Change from baseline in Alzheimer's disease assessment scale-cognitive subscale in week 8, 16 and 24
Time frame: Week 0, 8, 16, 24
4 secondary outcomes
Change from baseline in Mini Mental Status Examination at week 8, 16 and 24
Time frame: Week 0, 8, 16, 24
Change from baseline in Instrumental Activities of Daily Living at week 8, 16 and 24
Time frame: Week 0, 8, 16, 24
Change from baseline in Verbal learning and memory at week 24
Time frame: Week 0, 24
Change from baseline in Digit Span subtest of the Wechsler Memory Scale 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 4 Jun 2013.
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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.
Hsien-yuan Lane, MD, PhD study chair
Departments of Psychiatry, China Medical University Hospital, Taichung, Taiwan
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-B in people with Alzheimer's 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 8 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 4 Jun 2013. 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 Alzheimer's disease assessment scale-cognitive subscale in 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?
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 4 Jun 2013.