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Alzheimer Disease, Early OnsetPhase 2ROADNCT03625401

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

A Phase 2 study testing AD-35 60mg group in people with Alzheimer Disease, Early Onset, run by Zhejiang Hisun Pharmaceutical Co. Ltd. at 10 sites in United States.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

multi-center, randomized, double-blind, parallel-group,placebo-controlled study to evaluate the safety and tolerability, efficacy, and PK of 60 mg AD-35 administered QD during 6 months of double-blind treatment followed by a second 6 months of open-label treatment to subjects with mild to moderate AD. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Alzheimer Disease, Early Onset
What is being tested?
AD-35 60mg group
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
55 participants
Where
10 sitesUnited States
Study dates
4 Oct 2018to 31 Dec 2020
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must be diagnosed with probable AD in accordance with the National Institute on Aging and Alzheimer's Association (NIA-AA) (2011) criteria.
  • Subjects must have a Mini-Mental State Examination (MMSE) score of ≥15 and ≤26 at screening and baseline.
  • Subjects must have a brain magnetic resonance imaging (MRI) scan that is consistent with a clinical diagnosis of probable AD.
  • Subjects should not have received Aβ-based or tau-based treatment for AD.
  • Subjects who were previously treated with Acetyl cholinesterase inhibitor (AChEI) or memantine, must have been off of the therapy for at least 3 months prior to baseline assessments. Subjects who have been taking AChEI or memantine for ≤7 days may be considered for enrollment in this study.
  • For subjects who are currently receiving other non-excluded prescription or over-the-counter medications that might affect cognitive function (eg, non-anticholinergic antidepressants, atypical antipsychotics, non-benzodiazepine anxiolytics, soporifics, centrally acting anticholinergic antihistamines, centrally acting anticholinergic antispasmodics):
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  • Treatment must be at a stable dose for ≥1 month prior to randomization and throughout the duration of the study.
  • Treatment given intermittently and on a short-term basis must not be administered within 5 half-lives prior to the screening of neurocognitive assessments.
  • Subjects must be male or female between 50 years to 85 years of age (inclusive), at screening.
  • Female subjects must be post-menopausal for at least 2 consecutive years or surgically sterile (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 6 months prior to screening.
  • Male subjects with partners of reproductive potential must agree to use a reliable means of contraception (eg, minimum condom + spermicide) during the study and 30 days after discontinuing the study drug.
  • Subjects must have a reliable caregiver with contact at least 3 times per week (combination of face to face visits and telephone contact acceptable). The caregiver must be able to oversee the subject's compliance with study drug and participate in the subject's clinical assessment, to provide meaningful input into the NPI, ADCS-ADL, and CIBIC+.
  • Subjects (or subject's legally authorized representatives and their caregivers) must be able to provide informed consent.
  • Subjects (and their caregivers) must be able to read, write, speak, and understand English to ensure compliance with cognitive testing and study visit procedures.
  • Subjects (and their caregivers) must be willing and able to comply with the protocol's requirements.
  • Subjects must weigh between 45 kg and 90 kg (inclusive), at screening.
  • Subjects must be in general good health in the opinion of the Investigator, based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG) in triplicate, and clinical laboratory values.

Who cannot join

  • Lack of peripheral venous access.
  • Uncorrected impairment of vision or hearing that would preclude the subject from taking tests, or subjects lacking the ability to communicate.
  • Inability to tolerate MRI procedures or contraindication to MRI, including but not limited to MRI incompatible pacemakers; implantable cardioverter defibrillators; cochlear implants; cerebral aneurysm clips; implanted infusion pumps; implanted nerve stimulators; metallic splinters in the eye; other magnetic, electronic, or mechanical implants; or any other clinical history or examination finding that, in the judgment of the Investigator, would pose a potential hazard in combination with MRI.
  • Severe or unstable medical condition that, in the opinion of the Investigator or Sponsor, would interfere with the subject's ability to complete the study assessments.
  • History or presence of clinically evident vascular disease potentially affecting the brain (eg, stroke, clinically significant carotid or vertebral stenosis or plaque, aortic aneurysm, intracranial aneurysm, cerebral hemorrhage, arteriovenous malformation).
  • History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system trauma (eg, cerebral contusion).
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  • History or presence of intracranial tumor (eg, meningioma, glioma).
  • Presence of infections that affect the brain function or history of infections that resulted in neurologic sequelae (eg, syphilis, neuroborreliosis, viral or bacterial meningitis/encephalitis,human immunodeficiency virus encephalopathy).
  • History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease (eg, multiple sclerosis, lupus erythematosus, anti-phospholipid antibody syndrome, Behçet disease).
  • History or presence of psychiatric disease other than AD that may affect cognition or prevent completion of study procedures, including but not limited to clinically significant major psychiatric disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) (eg, major depression, schizophrenia, bipolar disorder).
  • A history of major depression is acceptable if no episode has been reported within the previous 5 years.
  • History or presence of a neurologic disease other than AD that may affect cognition, including but not limited to Parkinson's disease, corticobasal degeneration, dementia with Lewy bodies, Creutzfeldt-Jakob disease, progressive supranuclear palsy, frontotemporal degeneration, Huntington's disease, normal pressure hydrocephalus, and hypoxia.
  • History of seizures with the exception of childhood febrile seizures.
  • Known or suspected history of alcohol or drug abuse within the previous 5 years (DSM-V criteria).
  • Evidence of malignancies, acute infections, renal failure that requires dialysis, or other unstable medical disease not related to AD that in the Investigator's opinion would preclude subject participation.
  • This does not include any cancer (except adequately treated basal or squamous cell skin cancer) that is not being actively treated with anti-cancer drugs or radiotherapy as well as cancers that are considered to have low probability of recurrence (with supporting documentation of this from the treating oncologist, if possible).
  • History or presence of atrial fibrillation that poses a risk for future stroke in the Investigator's judgment.
  • Severe heart disease (history of myocardial infarction, congestive heart disease, history of unstable angina pectoris, clinically significant ECG abnormality) within 6 months prior to screening. Subjects with peripheral arterial disease will not be excluded if they are stable for at least 6 months prior to screening.
  • Clinically significant vital signs, laboratory, or ECG abnormalities (eg, abnormally prolonged or shortened heart rate, clinical significant arrhythmias, corrected QT interval [QTcF] >450 ms) in the Investigator's judgement. ECG abnormalities should be confirmed by Investigator based on the central read results provided by the ECG core laboratory (Medpace Cardiovascular Core Laboratory [MCCL]).
  • Subjects must not have an estimated glomerular filtration rate of <30 mL/min/1.73 m2, at screening.
  • Impaired hepatic function, as indicated by transaminases >2 times the upper limit of normal or abnormalities in synthetic function tests judged by the Investigator to be clinically significant.
  • Evidence of poorly-controlled diabetes (glycosylated hemoglobin >8.0%).
  • Presence of superficial siderosis of central nervous system, or >4 cerebral microhemorrhages, or evidence of a prior cerebral macrohemorrhage as assessed by T2*-weighted gradient-recalled-echo (GRE) MRI.
  • Presence of significant cerebral vascular pathology as assessed by MRI.
  • Treatment with any investigational agent within 5 half-lives or 4 weeks prior to screening, whichever is longer.
  • Cognitive dysfunction that might be due to past or current medication (eg, chemotherapy, steroids).
  • Treatment with any biologic therapy within 5 half-lives or 3 months prior to screening, whichever is longer, or any subject who has been in an Alzheimer Aβ or tau vaccination trial unless known to have received only placebo.
  • Treatment with anticholinergic antidepressants, typical antipsychotics, or barbiturates.
  • Chronic use of opiates, opioids, or benzodiazepines:
  • Intermittent short-term use is allowed except within 5 half-lives prior to any neurocognitive assessment.
  • Use or intention to use any medications/products that are cytochrome P450 (CYP)3A4 substrates with narrow therapeutic indexes.
  • Use or intention to use any medications/products that are known to be strong inducers/inhibitors of CYP3A4 within 7 days prior to the first dose and throughout the period of study drug administration.
  • Consumption of grapefruit juice or grapefruit-containing products within 7 days prior to the first dose and throughout the period of study drug administration.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • NeuroStudies

    Decatur, Georgia, 30033

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Alexian Brothers Neurosciences Institute

    Elk Grove Village, Illinois, 60007

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912

  • Meridien Research

    Maitland, Florida, 32751

  • Clinilabs, Inc.

    New York, New York, 10019

  • Northern California Research

    Sacramento, California, 95821

  • Pacific Research Network, Inc.

    San Diego, California, 92103

  • Meridien Research

    Spring Hill, Florida, 34609

  • Advanced Memory Research Institute of NJ

    Toms River, New Jersey, 08755

Other trials in United States

About this study

Official title: A Pilot, Phase 2a, Multi-Center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Safety and Tolerability, Efficacy, and Pharmacokinetics of AD-35 in Subjects With Mild to Moderate Alzheimer's Disease

multi-center, randomized, double-blind, parallel-group,placebo-controlled study to evaluate the safety and tolerability, efficacy, and PK of 60 mg AD-35 administered QD during 6 months of double-blind treatment followed by a second 6 months of open-label treatment to subjects with mild to moderate AD.

Read the detailed description

Approximately 55 subjects are planned to be enrolled for the entire study. Subjects will be randomized on Day 1 via a centralized interactive response technology (IRT) in a 1:2 ratio to receive placebo or 60 mg AD-35. The Data Safety Monitoring Board (DSMB) will review safety information after the first 30 subjects have completed the Day 30 Visit and make any necessary recommendations regarding changes to the conduct of the study.

After the first 6 months of double-blind treatment, subjects initially on placebo will transition to active study drug, and all subjects will receive 60 mg AD-35 for an additional 6 months of open-label treatment.

Being tested
AD-35 60mg group, Placebo group
Keywords
mild to moderate
Medical subject headings
Alzheimer Disease

What participants receive

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

  • AD-35 60mg groupDrug

    AD-35 60mg QD

  • Placebo groupDrug

    Placebo: 3 placebo of AD-35 30mg tablets

Study groups in NCT03625401
Study groupRoleWhat they receive
AD-35 60 mgExperimentalAD-35 60 mg group: 2 AD-35 30 mg tablets and 1 placebo tablet
Receives: Drug: AD-35 60mg group
Placebo of AD-35 30 mgPlacebo comparatorPlacebo group: 3 placebo tablets
Receives: Drug: Placebo group

What is being measured

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

  1. ADAS-cog 11 score

    The ADAS-cog 11 score is a 70-point scale administered by a clinician and is a standard measure to assess change in cognitive function in subjects with mild to moderate AD

    Measured: The primary efficacy endpoint will be change in the ADAS-cog 11 score from baseline to 6 months.

Secondary outcomes (4)

  1. NPI score

    NPI score identifies any changes for cognition, behavior, and global function and provide a measure of overall clinical improvement

    Measured: The secondary efficacy endpoint will be the change from baseline in the NPI score at 6 and 12 months

  2. ADCS-ADL score

    ADCS-ADL score identifies any changes for cognition, behavior, and global function and provide a measure of overall clinical improvement

    Measured: The secondary efficacy endpoint will be the change from baseline in the ADCS-ADL score at 6 and 12 months

  3. CIBIC+ score

    CIBIC+ score identifies any changes for cognition, behavior, and global function and provide a measure of overall clinical improvement

    Measured: The secondary efficacy endpoint will be the change from baseline in the CIBIC+ score at 6 and 12 months

  4. ADAS-cog 11 score

    The ADAS-cog 11 score is a 70-point scale administered by a clinician and is a standard measure to assess change in cognitive function in subjects with mild to moderate AD

    Measured: The secondary efficacy endpoint will be the change from baseline in ADAS-cog 11 score at 12 months

Timeline

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

  1. First posted10 Aug 2018
  2. Study start4 Oct 2018
  3. Primary completionDec 2020 (estimated)
  4. Study completion31 Dec 2020 (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
AD-35 60 mg group: 2 AD-35 30 mg tablets and 1 placebo tablet; Placebo group: 3 placebo tablets.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03625401
Sponsor's protocol ID
Hisun-AD-35-003
Acronym
ROAD
Status last verified
Mar 2020
First submitted
24 Jul 2018
Last updated
25 Mar 2020
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AD-35 60mg group in people with Alzheimer Disease, Early Onset, run by Zhejiang Hisun Pharmaceutical Co. Ltd. at 10 sites in United States.

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 17 inclusion and 33 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 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. 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?

ADAS-cog 11 score (time frame: The primary efficacy endpoint will be change in the ADAS-cog 11 score from baseline to 6 months.). 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 NCT03625401.

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 25 Mar 2020.

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