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

• Status: Unknown status
• Trial end date: 2018-06-30
• Target enrollment: 0
• Participant gender: All

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;

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Provincial People's Hospital; Zhejiang Provincial People’s Hospital
• Treatments: Anti-Anxiety Agents; Donepezil; Tandospirone

Criteria

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.