Effects of Huperzine A on Presbycusis(Δ,kHz, dB,MMSE, AD)

Cognitive Impairment Clinical Trial

Official title:

Effects of Huperzine A on Presbycusis-related Subjective Tinnitus and Cognitive Impairment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03101722
• Other study ID #: huadong FudanU
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2022
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the effects of huperzine A on tinnitus suppression, hearing and cognitive function protection in patients with presbycusis-related subjective tinnitus and cognitive impairment.

Description:

This study is a randomized, controlled trial. 60 eligible participants in total will be recruited. Participants in each group will be evenly and randomly assigned to the huperzine A subgroup and control subgroup using simple randomization method. Participants in the treatment subgroup will receive huperzine A (a dose of 0.2 mg/time, 2 times/day) with basic treatment and health education(BTHE), and those in the control subgroup will receive BTHE only. The primary outcome (auditory function) and secondary outcomes (tinnitus, cognitive symptom and quality of life) will be evaluated at baseline, 3-, 6-, 12-month follow-up.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 1, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

(1) 60 to 85 years old; (2) Mild-to-moderate sensorineural hearing loss (the pure tone averaged across octave frequencies between 0.25 to 4kHz of 26-70 dB HL), with subjective tinnitus, subjective cognitive decline or mild cognitive impairment; (3) Able to tolerate huperzine A treatment; (4) more than 3 months' experience of constant tinnitus; (5) Tinnitus Handicap Inventory score values >10; (6) No participation in any other clinical trial in the past 3 months; (7) Able to accomplish relevant tests and follow-up.

Exclusion Criteria:

(1) Conductive hearing loss; (2) current (3+ months) hearing aid(s) user; (3) Dependence due to poor physical activity; (4) Allergic to huperzine A; (5) History of malignancy within 5 years or other serious medical conditions before screening, including severe bradycardia, hypotension, angina, asthma, ileus, renal insufficiency, neurological diseases (e.g. epilepsy), psychiatric disorder (e.g. schizophrenia, severe depression and anxiety); (6) Acute brain trauma and stroke within 2 weeks; (7) history of general pain disorder and the use of pain relief drugs on a regular basis; (8) Patients who have started treatment or made changes in treatment with drugs known to influence tinnitus within 6 weeks before investigation starts. (9) Individuals simultaneously or previously (within 30 days prior to investigation start) participate in a clinical investigation using experimental drugs or devices. (10) Ongoing serious life event; (11) Vision impairment.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Presbycusis
• Tinnitus

Intervention

Drug:
• BTHE and Huperzine A
huperzine A intervention

Other:
• BETH
basic treatment and health education

Locations

Country	Name	City	State
China	Huadong Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zhijun Bao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse events related to treatment of Huperzine A	All participants (including with tinnitus and without tinnitus) will be observed gastrointestinal side effects (nausea, vomiting diarrhea)in yes or no, dizziness, fatigue and insomnia in yes or no	1years
Primary	hearing function protection	All participants (including with tinnitus and without tinnitus) will report in the measure.; ? value of averaged hearing threshold = re-test threshold - initial threshold, ? value of averaged hearing threshold = 0 showed good responders, and > 0 showed poor responders.	1 years
Secondary	global cognitive function protection	All participants (including with tinnitus and without tinnitus) will report in the outcome measure.; ?MMSE = re-test MMSE - initial MMSE, ?MMSE< 0 showed poor responders and hearing threshold = 0 showed good responders; and > 0 showed poor responders ?MMSE= 0 showed good responders	1 years
Secondary	special cognitive domains:orientation to time, orientation to place, registration, attention and calculations,recall, language,repetition and complex commands	MMSE scale in different domains (MMSE SCALE, 0-30)	1 years
Secondary	Tinnitus suppression	150 participants with tinnitus will report in the outcome measure. Method 1: tinnitus functional index (0~100,=25,relatively mild tinnitus; 25~50,significant problems with tinnitus; =50, tinnitus severe enough ). method 2:no effect on tinnitus was showed "0"; symptomatic alleviation was showed "1";and tinnitus disappear was showed "2"	1 years