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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2017

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Experimental group
  • Other: Control group

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • HAMA total score
    • Time Frame: week 12
    • HAMA total score at week 12
  • FAB score
    • Time Frame: week 12
    • FAB score at week 12
  • relative power
    • Time Frame: week 12
    • Change from baseline in the relative power at week 12
  • the image of PET
    • Time Frame: week 12
    • the image of PET at week 12
  • MMSE score
    • Time Frame: week 12
    • MMSE score at week 12

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zhejiang Provincial People’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Enyan Yu, Secretary of Party Committee – Zhejiang Provincial People’s Hospital

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