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

NCT ID: NCT03151382

Last Updated: 2017-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-20
• Study Completion Date: 2018-06-30

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;

Conditions

Alzheimer Disease; Cognitive Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Group Type: EXPERIMENTAL

Tandospirone Citrate

Intervention Type: DRUG

Tandospirone, 30-60 mg/d

Donepezil Hydrochloride

Intervention Type: DRUG

Donepezil, 10 mg/d

Control group

Group Type: OTHER

Donepezil Hydrochloride

Intervention Type: DRUG

Donepezil, 10 mg/d

Interventions

Tandospirone Citrate

Tandospirone, 30-60 mg/d

Intervention Type: DRUG

Donepezil Hydrochloride

Donepezil, 10 mg/d

Intervention Type: DRUG

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Enyan Yu

Secretary of Party Committee

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SED-AD-2016-001

Identifier Type: OTHER

Identifier Source: secondary_id

SED-AD

Identifier Type: -

Identifier Source: org_study_id