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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03151382
• Other study ID #: SED-AD
• Secondary ID: SED-AD-2016-001
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 8, 2017
• Last updated: May 10, 2017
• Start date: May 20, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: May 2017
• Source: Zhejiang Provincial People’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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;

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 30, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Function

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Provincial People’s Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of ADAS-cog total score	Change from baseline in ADAS-cog total score at week 12	week 12
Primary	NPI scale total score	NPI scale total score at week 12	week 12
Secondary	HAMA total score	HAMA total score at week 12	week 12
Secondary	FAB score	FAB score at week 12	week 12
Secondary	relative power	Change from baseline in the relative power at week 12	week 12
Secondary	the image of PET	the image of PET at week 12	week 12
Secondary	MMSE score	MMSE score at week 12	week 12