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

Study Overview
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Brief Summary
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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;

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

Conditions
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Alzheimer Disease, Cognitive Function

Intervention / Treatment
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* Drug: Tandospirone Citrate
* Drug: Donepezil Hydrochloride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br> | Drug: Tandospirone Citrate<br>* Tandospirone, 30-60 mg/d<br>Drug: Donepezil Hydrochloride<br>* Donepezil, 10 mg/d<br>|
| Other: Control group<br> | Drug: Donepezil Hydrochloride<br>* Donepezil, 10 mg/d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of ADAS-cog total score | Change from baseline in ADAS-cog total score at week 12 | week 12 | 
| NPI scale total score | NPI scale total score at week 12 | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAMA total score | HAMA total score at week 12 | week 12 | 
| FAB score | FAB score at week 12 | week 12 | 
| relative power | Change from baseline in the relative power at week 12 | week 12 | 
| the image of PET | the image of PET at week 12 | week 12 | 
| MMSE score | MMSE score at week 12 | week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer Disease, Cognitive Function, tandospirone