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;

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.