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

Zhejiang Provincial People's Hospital

Status and phase

Unknown

Phase 4

Conditions

Cognitive Function

Alzheimer Disease

Treatments

Drug: Tandospirone Citrate

Drug: Donepezil Hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

SED-AD-2016-001 (Other Identifier)

SED-AD

Details and patient eligibility

About

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;

Enrollment

30 estimated patients

Sex

All

Ages

55 to 80 years old

Volunteers

No 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.