Alzheimer DiseasePhase 4NCT03151382
A Based on PEEG and PET Study of Anxiolytic Treatment to Improve Cognitive Function in Patients With Alzheimer Disease
A Phase 4 study testing Tandospirone Citrate and Donepezil Hydrochloride in people with Alzheimer Disease and Cognitive Function, run by Zhejiang Provincial People's Hospital.
Trial summary
Objective: Evaluation the improvement of the cognitive function of tandospirone add-on treatment on patients with AD comorbid anxiety. Number of Patients: 30 Methodology: Randomized, open-label, parallel-group Assigned Interventions: Experimental: Tandospirone, 30-60 mg/d + Donepezil, 10 mg/d; Control group… Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Alzheimer Disease, Cognitive Function
- What is being tested?
- Tandospirone Citrate and Donepezil Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2017to 30 Jun 2018
- Phase
- Phase 4
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 55-80 years old (including 55 and 80), male or female, sufficient vision, hearing and general health to complete the follow-up and assessment;
- Patients who were diagnosed with AD according to the DSM-IV;
- MMSE score > 10 and ≤ 24;
- HAMA score > 8;
- HAMD score ≤ 7;
- Brain CT or MRI supports the diagnosis of AD;
- Provide written informed consent by the patient himself and his family member or guardian.
Who cannot join
- Dementia from any other cause;
- Brain MRI showed that the diameter of hyperintense lesions in T2-FLAIR sequences were larger than 5mm;
- Patients with significant cardiac, pulmonary, hepatic, renal, or hematologic disease;
- Any primary neurologic or psychiatric disease other than AD;
- Mental disorders due to substance abuse;
- Participation in other clinical studies within the last 30 days;
- History of alcohol or substance abuse or dependence within the past year;
- Pregnant or breastfeeding, or of child-bearing potential during the study.
About this study
Objective: Evaluation the improvement of the cognitive function of tandospirone add-on treatment on patients with AD comorbid anxiety.
Number of Patients: 30
Methodology: Randomized, open-label, parallel-group
Assigned Interventions: Experimental: Tandospirone, 30-60 mg/d + Donepezil, 10 mg/d; Control group: Donepezil, 10 mg/d.
Effect Evaluation: Primary Outcome: Change from baseline in ADAS-cog total score at week 12; NPI scale total score at week 12;
- Conditions
- Alzheimer Disease, Cognitive Function
- Being tested
- Tandospirone Citrate, Donepezil Hydrochloride
- Keywords
- Alzheimer Disease, Cognitive Function, tandospirone
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tandospirone CitrateDrug
Tandospirone, 30-60 mg/d
Donepezil HydrochlorideDrug
Donepezil, 10 mg/d
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Tandospirone Citrate; Drug: Donepezil Hydrochloride |
| Control group | Other | Not described Receives: Drug: Donepezil Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of ADAS-cog total score
Change from baseline in ADAS-cog total score at week 12
Measured: week 12
NPI scale total score
NPI scale total score at week 12
Measured: week 12
Secondary outcomes (5)
HAMA total score
HAMA total score at week 12
Measured: week 12
FAB score
FAB score at week 12
Measured: week 12
relative power
Change from baseline in the relative power at week 12
Measured: week 12
the image of PET
the image of PET at week 12
Measured: week 12
MMSE score
MMSE score at week 12
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start20 May 2017 (estimated)
- Primary completion31 Dec 2017 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enyan Yu, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151382
- Sponsor's protocol ID
- SED-AD
- Other IDs
- SED-AD-2016-001
- Status last verified
- May 2017
- First submitted
- 8 May 2017
- Last updated
- 12 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Based on PEEG and PET Study of Anxiolytic Treatment to Improve Cognitive Function in Patients With Alzheimer Disease
- ClinicalTrials.gov ID
- NCT03151382
- Acronym / sponsor ID
- SED-AD
- Conditions
- Alzheimer Disease, Cognitive Function
- Keywords
- Alzheimer Disease, Cognitive Function, tandospirone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Study start
- 20 May 2017 (estimated)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 12 May 2017 (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.
Objective: Evaluation the improvement of the cognitive function of tandospirone add-on treatment on patients with AD comorbid anxiety.
Number of Patients: 30
Methodology: Randomized, open-label, parallel-group
Assigned Interventions: Experimental: Tandospirone, 30-60 mg/d + Donepezil, 10 mg/d; Control group: Donepezil, 10 mg/d.
Effect Evaluation: Primary Outcome: Change from baseline in ADAS-cog total score at week 12; NPI scale total score at week 12;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Tandospirone Citrate, Drug: Donepezil Hydrochloride |
| Control group | Other | Drug: Donepezil Hydrochloride |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 55-80 years old (including 55 and 80), male or female, sufficient vision, hearing and general health to complete the follow-up and assessment;
- Patients who were diagnosed with AD according to the DSM-IV;
- MMSE score > 10 and ≤ 24;
- HAMA score > 8;
- HAMD score ≤ 7;
Key exclusion criteria (8 listed)
- Dementia from any other cause;
- Brain MRI showed that the diameter of hyperintense lesions in T2-FLAIR sequences were larger than 5mm;
- Patients with significant cardiac, pulmonary, hepatic, renal, or hematologic disease;
- Any primary neurologic or psychiatric disease other than AD;
- Mental disorders due to substance abuse;
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 |
|---|---|---|
| Tandospirone CitrateTandospirone, 30-60 mg/d | Drug | Experimental group |
| Donepezil HydrochlorideDonepezil, 10 mg/d | Drug | Control group, Experimental group |
Primary outcome
Change of ADAS-cog total score
Time frame: week 12
Change from baseline in ADAS-cog total score at week 12
NPI scale total score
Time frame: week 12
NPI scale total score at week 12
5 secondary outcomes
HAMA total score
Time frame: week 12
FAB score
Time frame: week 12
relative power
Time frame: week 12
the image of PET
Time frame: week 12
MMSE score
Time frame: week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tandospirone Citrate and Donepezil Hydrochloride in people with Alzheimer Disease and Cognitive Function, run by Zhejiang Provincial People's Hospital.
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 7 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: status not confirmed, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 of ADAS-cog total score (time frame: week 12). 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?
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 12 May 2017.