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

Primary Purpose

Alzheimer Disease, Cognitive Function

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tandospirone Citrate
Donepezil Hydrochloride
Sponsored by
Zhejiang Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer Disease, Cognitive Function, tandospirone

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Experimental group

    Control group

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    May 8, 2017
    Last Updated
    May 10, 2017
    Sponsor
    Zhejiang Provincial People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03151382
    Brief Title
    A Based on PEEG and PET Study of Anxiolytic Treatment to Improve Cognitive Function in Patients With Alzheimer Disease
    Official Title
    A Based on PEEG and PET Study of Anxiolytic Treatment to Improve Cognitive Function in Patients With Alzheimer Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 20, 2017 (Anticipated)
    Primary Completion Date
    December 31, 2017 (Anticipated)
    Study Completion Date
    June 30, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zhejiang Provincial People's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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;

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer Disease, Cognitive Function
    Keywords
    Alzheimer Disease, Cognitive Function, tandospirone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Title
    Control group
    Arm Type
    Other
    Intervention Type
    Drug
    Intervention Name(s)
    Tandospirone Citrate
    Intervention Description
    Tandospirone, 30-60 mg/d
    Intervention Type
    Drug
    Intervention Name(s)
    Donepezil Hydrochloride
    Intervention Description
    Donepezil, 10 mg/d
    Primary Outcome Measure Information:
    Title
    Change of ADAS-cog total score
    Description
    Change from baseline in ADAS-cog total score at week 12
    Time Frame
    week 12
    Title
    NPI scale total score
    Description
    NPI scale total score at week 12
    Time Frame
    week 12
    Secondary Outcome Measure Information:
    Title
    HAMA total score
    Description
    HAMA total score at week 12
    Time Frame
    week 12
    Title
    FAB score
    Description
    FAB score at week 12
    Time Frame
    week 12
    Title
    relative power
    Description
    Change from baseline in the relative power at week 12
    Time Frame
    week 12
    Title
    the image of PET
    Description
    the image of PET at week 12
    Time Frame
    week 12
    Title
    MMSE score
    Description
    MMSE score at week 12
    Time Frame
    week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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