Alzheimer Disease, Cognitive Function
Conditions
Keywords
Alzheimer Disease, Cognitive Function, tandospirone
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;
Interventions
DRUGTandospirone Citrate
Tandospirone, 30-60 mg/d
DRUGDonepezil Hydrochloride
Donepezil, 10 mg/d
Sponsors
Zhejiang Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of ADAS-cog total score | week 12 | Change from baseline in ADAS-cog total score at week 12 |
| NPI scale total score | week 12 | NPI scale total score at week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| relative power | week 12 | Change from baseline in the relative power at week 12 |
| HAMA total score | week 12 | HAMA total score at week 12 |
| MMSE score | week 12 | MMSE score at week 12 |
| the image of PET | week 12 | the image of PET at week 12 |
| FAB score | week 12 | FAB score at week 12 |
Outcome results
None listed