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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03151382
Recruitment Status : Unknown
Verified May 2017 by Enyan Yu, Zhejiang Provincial People's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : May 12, 2017
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Enyan Yu, Zhejiang Provincial People's Hospital

Study Description
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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;


Condition or disease Intervention/treatment Phase
Alzheimer Disease Cognitive Function Drug: Tandospirone Citrate Drug: Donepezil Hydrochloride Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Based on PEEG and PET Study of Anxiolytic Treatment to Improve Cognitive Function in Patients With Alzheimer Disease
Estimated Study Start Date : May 20, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental group Drug: Tandospirone Citrate
Tandospirone, 30-60 mg/d

Drug: Donepezil Hydrochloride
Donepezil, 10 mg/d
Control group Drug: Donepezil Hydrochloride
Donepezil, 10 mg/d


Outcome Measures
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Primary Outcome Measures :
  1. Change of ADAS-cog total score [ Time Frame: week 12 ]
    Change from baseline in ADAS-cog total score at week 12

  2. NPI scale total score [ Time Frame: week 12 ]
    NPI scale total score at week 12


Secondary Outcome Measures :
  1. HAMA total score [ Time Frame: week 12 ]
    HAMA total score at week 12

  2. FAB score [ Time Frame: week 12 ]
    FAB score at week 12

  3. relative power [ Time Frame: week 12 ]
    Change from baseline in the relative power at week 12

  4. the image of PET [ Time Frame: week 12 ]
    the image of PET at week 12

  5. MMSE score [ Time Frame: week 12 ]
    MMSE score at week 12


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Enyan Yu, Secretary of Party Committee, Zhejiang Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT03151382    
Other Study ID Numbers: SED-AD
SED-AD-2016-001 ( Other Identifier: Sumitomo Pharma （Suzhou） Co..Ltd )
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enyan Yu, Zhejiang Provincial People's Hospital:
Alzheimer Disease
Cognitive Function
tandospirone
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Tandospirone
Donepezil
Molecular Mechanisms of Pharmacological Action
 Cholinesterase Inhibitors
Enzyme Inhibitors
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents