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

Sponsor

Zhijun Bao (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03101722

Collaborator

(none)

Enrollment

Location

Arms

78.6

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Presbycusis Tinnitus Cognitive Impairment	Drug: BTHE and Huperzine A Other: BETH	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The studies were divided into 2 groups: Control subgroup and huperzine A group.The study is a single-center, randomized, basic treatment and health education controlled trial, with minimized allocation of patients to one of the two groups. For the study of tinnitus intervention, there is a 3 to 12 month follow-up.The studies were divided into 2 groups: Control subgroup and huperzine A group.The study is a single-center, randomized, basic treatment and health education controlled trial, with minimized allocation of patients to one of the two groups. For the study of tinnitus intervention, there is a 3 to 12 month follow-up.

Masking:

Single (Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 15, 2017

Anticipated Primary Completion Date :

May 15, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Huperzine A intervention Huperzine A intervention: Huperzine A with a dose 0.1~0.2 mg/time, 2 times/day. BTHE：basic treatment and health education	Drug: BTHE and Huperzine A huperzine A intervention Other Names: acetylcholinesterase inhibitor Other: BETH basic treatment and health education
Sham Comparator: control Participants in the BTHE group will receive advice regarding lifestyle modification, avoiding alcohol and cigarette consumption.	Drug: BTHE and Huperzine A huperzine A intervention Other Names: acetylcholinesterase inhibitor Other: BETH basic treatment and health education

Arm

Intervention/Treatment

Experimental: Huperzine A intervention

Huperzine A intervention: Huperzine A with a dose 0.1~0.2 mg/time, 2 times/day. BTHE：basic treatment and health education

Drug: BTHE and Huperzine A

huperzine A intervention

Other Names:

acetylcholinesterase inhibitor

Other: BETH

basic treatment and health education

Sham Comparator: control

Participants in the BTHE group will receive advice regarding lifestyle modification, avoiding alcohol and cigarette consumption.

Drug: BTHE and Huperzine A

huperzine A intervention

Other Names:

acetylcholinesterase inhibitor

Other: BETH

basic treatment and health education

Outcome Measures

Primary Outcome Measures

hearing function protection [1 years]
All participants (including with tinnitus and without tinnitus) will report in the measure. Δ value of averaged hearing threshold = re-test threshold - initial threshold, Δ value of averaged hearing threshold ≤ 0 showed good responders, and > 0 showed poor responders.

Secondary Outcome Measures

global cognitive function protection [1 years]
All participants (including with tinnitus and without tinnitus) will report in the outcome measure. ΔMMSE = re-test MMSE - initial MMSE, ΔMMSE< 0 showed poor responders and hearing threshold ≤ 0 showed good responders; and > 0 showed poor responders ΔMMSE≥ 0 showed good responders
special cognitive domains:orientation to time, orientation to place, registration, attention and calculations,recall, language,repetition and complex commands [1 years]
MMSE scale in different domains (MMSE SCALE, 0-30)
Tinnitus suppression [1 years]
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"

Other Outcome Measures

adverse events related to treatment of Huperzine A [1years]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huadong Hospital	Shanghai	Shanghai	China	200040

Sponsors and Collaborators

Zhijun Bao

Investigators

Study Director: zhuowei yu, MD, Shanghai Institute of Geriatrics and Gerontology, Shanghai Key Laboratory of Clinical Geriatrics, Huadong Hospital, and Research Center of Aging and Medicine, Shanghai Medical College, Fudan University, Shanghai 200040, China.