A Based on PEEG and PET Study of Anxiolytic Treatment to Improve Cognitive Function in Patients With Alzheimer Disease

NCT03151382 — Phase 4, Unknown, 30 participants, Zhejiang Provincial People's Hospital

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Registry	NCT03151382
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	30 (Estimated)
Sponsor	Zhejiang Provincial People's Hospital (Other)
Conditions	Alzheimer Disease, Cognitive Function
Interventions	Tandospirone Citrate, Donepezil Hydrochloride (Drug)
Dates	start 2017-05-20 (estimated), primary completion 2017-12-31 (estimated), completion 2018-06-30 (estimated), first posted 2017-05-12, last updated 2017-05-12

-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: 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;

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+Arms and interventions

Arm	Type	Interventions	Description
Experimental group	Experimental	Drug: Tandospirone Citrate; Drug: Donepezil Hydrochloride
Control group	Other	Drug: Donepezil Hydrochloride

Tandospirone Citrate (Drug): Tandospirone, 30-60 mg/d
Donepezil Hydrochloride (Drug): Donepezil, 10 mg/d

+Outcome measures

Primary outcomes

Change of ADAS-cog total score [week 12]: Change from baseline in ADAS-cog total score at week 12
NPI scale total score [week 12]: NPI scale total score at week 12

Secondary outcomes

HAMA total score [week 12]: HAMA total score at week 12
FAB score [week 12]: FAB score at week 12
relative power [week 12]: Change from baseline in the relative power at week 12
the image of PET [week 12]: the image of PET at week 12
MMSE score [week 12]: MMSE score at week 12

+Eligibility

Sex: All, ages: 55 Years to 80 Years

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

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