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Alzheimer's DiseasePhase 2WAYNCT03790982

Evaluate the Safety and Efficacy of AD-35 Tablet in Subjects With Mild to Moderate Alzheimer's Disease

A Phase 2 study testing AD-35 60 mg in people with Alzheimer's Disease, run by Zhejiang Hisun Pharmaceutical Co. Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Brief summary: This is a phase II study to investigate the safety, preliminary efficacy and pharmacokinetics of AD-35 tablet in patients with mild to moderate Alzheimer's Disease. This study is to be run in China involving 21 sites. Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
AD-35 60 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
1 siteChina
Study dates
1 Dec 2018to 30 Jul 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women, 50-75 years of age.
  • Formal education of five or more years.
  • Diagnosed of probable AD in accordance with the NINCDS/ADRDA criteria (2011).
  • Mild or moderate AD subjects: MMSE Score of 15-26 and CDR Score ≥ 0.5 (CDR memory score ≥ 0.5).
  • Subjects must have a brain magnetic resonance imaging (MRI) scan that is consistent with a clinical diagnosis of probable AD. Brain atrophy and medial temporal lobe atrophy visual assessment scale MTA grading >2 points. Mild white matter degeneration may occur, but Fazekas less than or equal to 2 points and supratentorial lacunar infarction lesions less than or equal to 3 points.
  • The total score of modified Hachinski ischemia scale (MHIS) ≤ 4.
  • Hamilton depression scale (HAMD) has a total score ≤ 17.

Who cannot join

  • Visual, hearing and verbal communication of subjects cannot meet the needs of cognitive function evaluation.
  • Inability to tolerate MRI procedures or contraindication to MRI, (such as implanted in the body, MRI incompatible pacemakers, implantable cardioverter defibrillators, cochlear implants, aneurysm clips, implanted injection pump, implanted nerve stimulator, metallic splinters in the eye, other magnetic, electrical and other metal implants) [note], or any other situation, in the judgment of the Investigator, is not suitable for magnetic resonance imaging (MRI).
  • The investigators believe that other severe or unstable conditions may interfere with the cognitive evaluation in clinical trials.
  • Dementia caused by other reasons: vascular dementia, central nervous system infection, endocrine system diseases (such as thyroid disease, parathyroid gland disease) and other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Department of Neurosurgery

    Beijing, Beijing Municipality, 100010

Other trials in China

About this study

Official title: A Randomized, Double Blind, Placebo Controlled, Parallel-Group 52-week Multicenter Phase II Study to Investigate the Safety, Efficacy and Pharmacokinetics of AD-35 Tablet in Subjects With Mild to Moderate Alzheimer's Disease

Brief summary: This is a phase II study to investigate the safety, preliminary efficacy and pharmacokinetics of AD-35 tablet in patients with mild to moderate Alzheimer's Disease. This study is to be run in China involving 21 sites. It will enroll approximately 480 patients to ensure 240 randomized with mild to moderate Alzheimer's Disease. The treatment period is 52 weeks and total study duration per patient is approximately 57 weeks.

Read the detailed description

In this multicenter, randomized, double blind, parallel-group, placebo controlled phase II study, 240 patients with mild to moderate Alzheimer's Disease are planned to be enrolled and randomly assigned 1:1:1 to receive placebo, or different doses of AD-35 tablet (30 or 60 mg). After the first 26 weeks, subjects on active study drug will remain on the current doses, and subjects assigned to placebo will be randomized to receive 30 mg and 60 mg AD-35 tablet in a 1:1 ratio, respectively, for the second 26 weeks. This study will evaluate the safety, preliminary efficacy and pharmacokinetics of AD-35 tablets in patients with mild to moderate Alzheimer's Disease.

Being tested
Placebo of AD-35 60mg /AD-35 30mg, Placebo of AD-35 60mg /AD-35 60mg, AD-35 30 mg + Placebo of AD-35 30 mg, AD-35 60 mg
Keywords
AD-35 tablet, Alzheimer's Disease, Phase II study
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo of AD-35 60mg /AD-35 30mgDrug

    Also called Placebo of AD-35

    Placebo 60mg, oral, 1st 26 weeks; AD-35 30mg +Placebo of AD-35 30mg oral 2nd 26 weeks.

  • Placebo of AD-35 60mg /AD-35 60mgDrug

    Also called Placebo 60mg

    Placebo 60mg, oral, 1st 26 weeks; AD-35 60mg oral, 2nd 26 weeks.

  • AD-35 30 mg + Placebo of AD-35 30 mgDrug

    Also called AD-35

    AD-35 30 mg + Placebo of AD-35 30 mg AD-35 30 mg + Placebo of AD-35 30 mg, Oral, 52 weeks.

  • AD-35 60 mgDrug

    Also called AD-35

    AD-35 60 mg AD-35 30 mg x two tablets, oral, 52 weeks.

Study groups in NCT03790982
Study groupRoleWhat they receive
Placebo of AD-35 60mg /AD-35 30mgPlacebo comparatorPlacebo of AD-35 60 mg Placebo of AD-35 30mg x two tablets, once daily in the first 26 weeks (oral), then AD-35 30mg +Placebo of AD-35 30mg, once daily in the second 26 weeks (oral)
Receives: Drug: Placebo of AD-35 60mg /AD-35 30mg
Placebo of AD-35 60mg /AD-35 60mgPlacebo comparatorPlacebo of AD-35 60 mg Placebo of AD-35 30mg x two tablets, once daily in the first 26 weeks (oral), then AD-35 30mg x two tablets, once daily in the second 26 weeks (oral)
Receives: Drug: Placebo of AD-35 60mg /AD-35 60mg
AD-35 30 mg+Placebo of AD-35 30 mgExperimentalAD-35 30 mg + Placebo of AD-35 30 mg AD-35 30 mg + Placebo of AD-35 30 mg, once daily for 52 weeks (oral)
Receives: Drug: AD-35 30 mg + Placebo of AD-35 30 mg
AD-35 60 mgExperimentalAD-35 60 mg AD-35 30 mg× two tablets, once daily for 52 weeks (oral)
Receives: Drug: AD-35 60 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) 11 scores

    Changes in the total of ADAS-Cog11 scores of treatment compared with baseline. The score ranged from 0 to 75, and the higher the score, the greater the cognitive impairment

    Measured: Week 26

  2. Changes in Alzheimer's Disease Cooperative Study-clinical global impression of change (ADCS-CGIC ) scores

    Changes in ADCS-CGIC scores of treatment compared with baseline. The overall condition of the disease change is assessed (improved or deteriorated) by the doctor and the patient, and the 8-point scoring method (0-7 points) was adopted.

    Measured: Week 26

Secondary outcomes (1)

  1. Changes in ADAS-Cog11 scores

    Changes in ADCS-CGIC scores of treatment compared with baseline

    Measured: Week 6, week 13, week 39, week52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2019
  2. Study start1 Dec 2018
  3. Primary completion30 Dec 2020 (estimated)
  4. Study completion30 Jul 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment, Multiple Groups, Multiple Centers
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03790982
Sponsor's protocol ID
AD-35-II-01
Acronym
WAY
Status last verified
Dec 2018
First submitted
18 Dec 2018
Last updated
2 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AD-35 60 mg in people with Alzheimer's Disease, run by Zhejiang Hisun Pharmaceutical Co. Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) 11 scores (time frame: Week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03790982.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2019.

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