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

Phase 4

• Conditions: Cognitive Function; Alzheimer Disease
• Interventions: Drug: Tandospirone Citrate; Drug: Donepezil Hydrochloride

• Registration Number: NCT03151382
• Lead Sponsor: Zhejiang Provincial People's Hospital

Brief 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;

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-10
• Last Update Submitted: 2017-05-10
• Study First Posted: 2017-05-12
• Last Update Posted: 2017-05-12
• Study Start: 2017-05-20
• Primary Completion: 2017-12-31
• Study Completion: 2018-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Tandospirone Citrate	-
Experimental group	Donepezil Hydrochloride	-
Control group	Donepezil Hydrochloride	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
relative power	week 12	Change from baseline in the relative power at week 12
FAB score	week 12	FAB score 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
HAMA total score	week 12	HAMA total score at week 12