Behavioral and Psychological Symptoms in Alzheimer's DiseasePhase 2NCT02103673
DAOIB for the Treatment of Cognitive Function and Behavioral and Psychological Symptoms of Dementia
A Phase 2 study testing DAOIB in people with Behavioral and Psychological Symptoms in Alzheimer's Disease and Behavioral and Psychological Symptoms in Vascular Dementia, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
Trial summary
The population of dementia is increasing rapidly. Cognitive impairment as well as Behavioral and psychological symptoms of dementia (BPSD) add heavy burdens to caregiver. NMDA activation is critical for learning and memory. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Behavioral and Psychological Symptoms in Alzheimer's Disease, Behavioral and Psychological Symptoms in Vascular Dementia
- What is being tested?
- DAOIB
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesTaiwan
- Study dates
- Feb 2014to Nov 2017
- 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 probable Alzheimer's disease or probable vascular dementia
- For patients with vascular dementia, the post-stroke period must be more than 3 months
- Mini-Mental State scores between 5-26
- Clinical Dementia Rating score equal to or greater than 1
- Behavioral Pathology in Alzheimer's Disease Rating Scale score equal to or greater than 2
Who cannot join
- Current substance abuse or history of substance dependence in the past 6 months
- Other major psychiatric diagnoses, such as schizophrenia, major depressive disorder, bipolar disorder and mental retardation etc.
- Serious medical or neurological illness other than Alzheimer's disease/vascular dementia and other secondary dementia
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Chang Gung Memorial Hospital
Kaohsiung City, 886
China Medical University Hospital
Taichung, 886
About this study
The population of dementia is increasing rapidly. Cognitive impairment as well as Behavioral and psychological symptoms of dementia (BPSD) add heavy burdens to caregiver. NMDA activation is critical for learning and memory. Individuals with Alzheimer's disease (AD) have fewer NMDA receptors in the frontal cortex and hippocampus than controls. This study is a randomized, double-blind, placebo-controlled drug trial. All patients will be allocated randomly to two groups: (1) NMDA enhancer: DAOIB (starting dosage: 250-500 mg/day), (2) placebo, for 6 weeks. The investigators hypothesize that DAOIB may yield better efficacy than placebo for cognitive function and clinical symptoms in patients with BPSD.
- Conditions
- Behavioral and Psychological Symptoms in Alzheimer's Disease, Behavioral and Psychological Symptoms in Vascular Dementia
- Being tested
- DAOIB, Placebo
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAOIBDrug
Intervention drug: DAOIB. Dosage: 250-1500 mg/day by mouth. Duration: 6 weeks
PlaceboDrug
Intervention drug: placebo by mouth. Duration: 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| DAOIB | Experimental | Drug: DAOIB 250-1500 mg/day by mouth for 6 weeks Receives: Drug: DAOIB |
| Placebo | Placebo comparator | Placebo by mouth per day for 6 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Pathology in Alzheimer's Disease Rating Scale
Change from baseline in Behavioral Pathology in Alzheimer's Disease Rating Scale at weeks 2, 4 and 6
Measured: weeks 0, 2, 4, 6
Alzheimer's Disease Assessment Scale - cognitive subscale
Change from baseline in Alzheimer's Disease Assessment Scale - cognitive subscale at week 6
Measured: weeks 0 and 6
Secondary outcomes (5)
Neuropsychiatirc Inventory
Change from baseline in Neuropsychiatirc Inventory at week 6
Measured: weeks 0 and 6
Instrumental Activities of Daily Living
Changes from baseline in Instrumental Activities of Daily Living at week 6
Measured: weeks 0 and 6
Zarit Caregiver Burden Interview
Changes from baseline in Zarit Caregiver Burden Interview at week 6
Measured: weeks 0 and 6
Geriatric Geriatric Depression Scale
Changes from baseline in Geriatric Depression Scale at weeks 2, 4 and 6
Measured: weeks 0, 2, 4, 6
Mini-Mental Status Examination
Changes from baseline in Mini-Mental Status Examination at week 6
Measured: weeks 0 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionNov 2017
- Study completionNov 2017
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 Behavioral and Psychological Symptoms in 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chieh-Hsin Lin, Chang Gung Memorial Hospital
- Investigators
- Hsien-Yuan Lane, MD, PhD, Study chair, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103673
- Sponsor's protocol ID
- 102-0035C
- Status last verified
- Jan 2018
- First submitted
- 1 Apr 2014
- Last updated
- 24 Jan 2018
- Results posted
- No
Publications
Lin CH, Chen PK, Wang SH, Lane HY. Effect of Sodium Benzoate on Cognitive Function Among Patients With Behavioral and Psychological Symptoms of Dementia: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 Apr 1;4(4):e216156. doi: 10.1001/jamanetworkopen.2021.6156.
PubMed 33881530Lin CH, Yang HT, Chen PK, Wang SH, Lane HY. Precision Medicine of Sodium Benzoate for the Treatment of Behavioral and Psychological Symptoms of Dementia (BPSD). Neuropsychiatr Dis Treat. 2020 Feb 20;16:509-518. doi: 10.2147/NDT.S234371. eCollection 2020.
PubMed 32110025
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DAOIB for the Treatment of Cognitive Function and Behavioral and Psychological Symptoms of Dementia
- ClinicalTrials.gov ID
- NCT02103673
- Acronym / sponsor ID
- 102-0035C
- Conditions
- Behavioral and Psychological Symptoms in Alzheimer's Disease, Behavioral and Psychological Symptoms in Vascular Dementia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 4 Apr 2014 (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.
The population of dementia is increasing rapidly. Cognitive impairment as well as Behavioral and psychological symptoms of dementia (BPSD) add heavy burdens to caregiver. NMDA activation is critical for learning and memory. Individuals with Alzheimer's disease (AD) have fewer NMDA receptors in the frontal cortex and hippocampus than controls. This study is a randomized, double-blind, placebo-controlled drug trial. All patients will be allocated randomly to two groups: (1) NMDA enhancer: DAOIB (starting dosage: 250-500 mg/day), (2) placebo, for 6 weeks. The investigators hypothesize that DAOIB may yield better efficacy than placebo for cognitive function and clinical symptoms in patients with BPSD.
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 |
|---|---|---|
| DAOIB | Experimental | Drug: DAOIBDrug: DAOIB 250-1500 mg/day by mouth for 6 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo by mouth per day for 6 weeks |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of probable Alzheimer's disease or probable vascular dementia
- For patients with vascular dementia, the post-stroke period must be more than 3 months
- Mini-Mental State scores between 5-26
- Clinical Dementia Rating score equal to or greater than 1
- Behavioral Pathology in Alzheimer's Disease Rating Scale score equal to or greater than 2
Key exclusion criteria (3 listed)
- Current substance abuse or history of substance dependence in the past 6 months
- Other major psychiatric diagnoses, such as schizophrenia, major depressive disorder, bipolar disorder and mental retardation etc.
- Serious medical or neurological illness other than Alzheimer's disease/vascular dementia and other secondary dementia
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 |
|---|---|---|
| DAOIBIntervention drug: DAOIB. Dosage: 250-1500 mg/day by mouth. Duration: 6 weeks | Drug | DAOIB |
| PlaceboIntervention drug: placebo by mouth. Duration: 6 weeks | Drug | Placebo |
Primary outcome
Behavioral Pathology in Alzheimer's Disease Rating Scale
Time frame: weeks 0, 2, 4, 6
Change from baseline in Behavioral Pathology in Alzheimer's Disease Rating Scale at weeks 2, 4 and 6
Alzheimer's Disease Assessment Scale - cognitive subscale
Time frame: weeks 0 and 6
Change from baseline in Alzheimer's Disease Assessment Scale - cognitive subscale at week 6
5 secondary outcomes
Neuropsychiatirc Inventory
Time frame: weeks 0 and 6
Instrumental Activities of Daily Living
Time frame: weeks 0 and 6
Zarit Caregiver Burden Interview
Time frame: weeks 0 and 6
Geriatric Geriatric Depression Scale
Time frame: weeks 0, 2, 4, 6
Mini-Mental Status Examination
Time frame: weeks 0 and 6
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 24 Jan 2018.
- Derived from this study: PubMed 33881530Lin CH, Chen PK, Wang SH, Lane HY. Effect of Sodium Benzoate on Cognitive Function Among Patients With Behavioral and Psychological Symptoms of Dementia: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 Apr 1;4(4):e216156. doi: 10.1001/jamanetworkopen.2021.6156.
- Derived from this study: PubMed 32110025Lin CH, Yang HT, Chen PK, Wang SH, Lane HY. Precision Medicine of Sodium Benzoate for the Treatment of Behavioral and Psychological Symptoms of Dementia (BPSD). Neuropsychiatr Dis Treat. 2020 Feb 20;16:509-518. doi: 10.2147/NDT.S234371. eCollection 2020.
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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
China Medical University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DAOIB in people with Behavioral and Psychological Symptoms in Alzheimer's Disease and Behavioral and Psychological Symptoms in Vascular Dementia, run by Chang Gung Memorial Hospital at 2 sites 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 5 inclusion and 3 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 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Behavioral Pathology in Alzheimer's Disease Rating Scale (time frame: weeks 0, 2, 4, 6). The study lists 2 primary outcomes in all. 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 NCT02103673, 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 24 Jan 2018.