Tenofovir Disoproxil Fumarate in the Treatment of Parkinson's Disease

Phase 1

Recruiting

• Conditions: Parkinson Disease
• Interventions: Drug: Tenofovir Disoproxil Fumarate

• Registration Number: NCT06356662
• Lead Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Brief Summary

To evaluate the efficacy and safety of tenofovir disoproxil fumarate in the treatment of Parkinson's disease. The changes of motor symptoms and the occurrence of adverse reactions in early Parkinson's disease patients who took tenofovir disoproxil fumarate and did not take Tenofovir disoproxil fumarate at different time points were compared.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-23
• Study First Submitted: 2024-03-27
• Study First Submitted QC: 2024-04-07
• Study First Posted: 2024-04-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-17
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1: Parkinson's disease: Hoehn Yahr= 1 to 2.5 2: MMSE score≥24

Exclusion Criteria

• 1: essential tremor, stroke, epilepsy and other well-defined neurological disorders

  2: Or have received deep brain stimulation and other brain surgery

  3: Abnormal liver and kidney function

  4: Infected with chronic hepatitis B or AIDS (HIV-1 infection)

  5: Severe depression, schizophrenia, other psychiatric disorders or drug dependence

  6: Other serious physical diseases such as heart, lung, liver, kidney disease, blood disease and malignant tumor

  7: Pregnant or lactating women and seniors over 65 years of age

  8: Allergy or other contraindications to the investigational drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenofovir	Tenofovir Disoproxil Fumarate	patients with parkinson's disease
Placebo	Tenofovir Disoproxil Fumarate	patients with parkinson's disease

Primary Outcome Measures

Name	Time	Method
UPDRS III（Unified Parkinson's Disease Rating Scale part 3）	1 month、3 month	score：0-132，higher scores mean a worse outcome

Secondary Outcome Measures

Name	Time	Method
creatinine(μmoI/L)	1 month、3 month	blood biochemistry test，normal\<97μmoI/L
Non-Motor Symptom Scale（NMSS）	1 month、3 month	score：0-360，higher scores mean a worse outcome

Trial Locations

Locations (1)

Guohua Zhao; 🇨🇳 Hangzhou, Zhejiang, China