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Alzheimer DiseasePhase 2/3NCT03790709

ANAVEX2-73 for Treatment of Early Alzheimer's Disease

A Phase 2/3 study testing High dose ANAVEX2-73 and Mid dose ANAVEX2-73 in people with Alzheimer Disease, run by Anavex Life Sciences Corp. at 54 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase 2b/3 48-week study to evaluate the effects of ANAVEX2-73 on cognition and function after 48 weeks of daily treatment. Additional outcome measures include refined measures of sleep, behavioral and psychological symptoms typically observed in AD, changes in daily functioning of participants and changes in… Read more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Alzheimer Disease
What is being tested?
High dose ANAVEX2-73 and Mid dose ANAVEX2-73
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
509 participants
Where
54 sitesin 5 countries
Study dates
3 Jul 2018to 30 Jun 2022
Phase
Phase 2/3
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 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 60 to 85 years, inclusive, with a NIA-AA diagnosis of mild cognitive impairment (MCI) due to AD or early stage mild dementia due to AD. AD diagnosis should be made by an appropriately qualified medical specialist and AD pathology should be confirmed by either:
  • Historical records of amyloid CSF assessment or
  • Historical records of amyloid PET scan or
  • If neither historical records are available, then AD pathological diagnosis confirmation should be offered at screening:
  • CSF collection or ii. Amyloid PET iii. Past medical records of MRI or CT are optional.
  • Mini Mental State Examination (MMSE) score between 20-28, inclusive.
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  • Free Recall score ≤17 or Total Recall score <40 on the Free and Cued Selective Reminding Test (FCSRT).
  • Participants are either outpatients, or residents of an assisted-living facility. Participant has a designated study partner, who spends at least 10hrs per week with the participant, in order that assessments e.g. carer burden instruments are completed with true knowledge of the participant.
  • No suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (C-SSRS) in the past 3 months (i.e. active suicidal thought(s) with intent but without specific plan, or active suicidal thought(s) with plan and intent) OR suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
  • Confirmation from the participant that, if of childbearing potential is not pregnant through urine pregnancy testing.

Who cannot join

  • Patients who have a progressive medical or neurological condition that in the opinion of the investigator would interfere with the conduct of the study. Exception: If diagnosed with seizures, must be on stable anti-seizure medication for at least 3 months prior to screening.
  • Current clinically significant systemic illness that is likely to result in deterioration of the patient's condition or affect the patient's safety during the study.
  • History or clinically evident stroke or clinically significant carotid or vertebrobasilar stenosis or plaque.
  • History of neurologic (e.g. stroke, traumatic brain injury) or psychiatric condition that the investigator deems may interfere with interpretability of data.
  • History of untreated thyroid disorder, Type 1 diabetes, and insulin dependent or uncontrolled Type II diabetes, as determined by the investigator (e.g. non-insulin-controlled Type II diabetes, whose HbA1c value is higher than 8.0%).
  • Body Mass Index (BMI) > 30.
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  • History of clinical hepatic dysfunction.
  • Current symptomatic and unstable/uncontrolled gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hematological or hormonal disorders.
  • Indication of liver disease, defined by serum levels of ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3x upper limit of normal (ULN) as determined during screening.
  • Significant history of drug addiction (with the exception of nicotine dependence) or abuse (including alcohol, as defined in DSM-V or in the opinion of the investigator) within the last two years prior to informed consent, or a positive urine drug screen for cocaine, opioid, phencyclidine (PCP), amphetamine or marijuana at screening. Prescription medication yielding a positive drug screen are acceptable except for tricyclic antidepressants (e.g. Amitriptyline, Amoxapine, Desipramine, (Norpramin) Doxepin, Imipramine (Tofranil), Nortriptyline (Pamelor), Protriptyline (Vivactil), Trimipramine (Surmontil)).
  • Clinically significant infection within the last 30 days prior screening (e.g., chronic persistent or acute infection, urinary tract infections (UTI)).
  • Treatment with immunosuppressive medications (e.g., systemic corticosteroids) within the last 90 days (topical and nasal corticosteroids and inhaled corticosteroids for asthma are permitted) or chemotherapeutic agents for malignancy within the last 3 years.
  • Myocardial infarction within the last year.
  • History of cancer within the last 3 years, with the exception of basal cell carcinoma and non-metastatic squamous cell carcinoma of the skin and prostate cancer with currently normal PSA.
  • Other clinically significant abnormality on physical, neurological, laboratory, or electrocardiogram (ECG) examination (e.g., atrial fibrillation) that could compromise the study or be detrimental to the participant.
  • Hemoglobin < 11 g/dL.
  • Have any contraindication to MRI scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (e.g., in skull and cardiac devices or severe claustrophobia).
  • Smoking > 1 pack of cigarettes per day (as assessed for the 30 days prior to screening).
  • Alcohol use of more than 2 drinks per day.
  • Current use of over-the-counter (OTC) supplements or nutraceuticals unless they are on stable dose for at least 3 months prior to screening and are documented in the eCRF.
  • Use of over the counter (OTC) or prescription medication for sleep on 2 or more occasions per week.
  • Being treated with psychoactive medications on a stable dose for less than 3 month.
  • Any prior exposure to ANAVEX2-73.
  • Individuals enrolled in previous AD clinical trial involving an investigational drug treatment less than 3 months ago (longer than 3 month ago allowed).
  • Any known hypersensitivity to any of the excipients contained in the study drug formulation.
  • Any other criteria (such as a clinically significant screening blood test result), which in the opinion of the Investigator causes the participant not to qualify for the study.
  • Evidence of cerebrovascular dementia with a Hachinski score of 4 or more.

Trial locations and contacts

54 sites in 5 countries.

54 sites in 5 countries

Australia16 sites

  • The Royal Adelaide Hospital (RAH) and The Queen Elizabeth Hospital (TQEH)

    Adelaide, South Australia

  • Central Coast Neurosciences Research

    Central Coast, New South Wales

  • Penninsula Therapeutic and Research Group

    Frankston, Victoria

  • Geelong Private Medical Centre

    Geelong, Victoria

  • Delmont Private Hospital

    Glen Iris, Victoria

  • Hornsby (Northern Sydney Health)

    Hornsby, New South Wales

  • KaRa MINDS

    Macquarie Park, New South Wales

  • Hammond Care

    Malvern, Victoria

  • Alfred Health

    Melbourne, Victoria

  • Austin Health

    Melbourne, Victoria

  • Monash Alfred Psychiatry Research Centre

    Melbourne, Victoria

  • McCusker

    Nedlands, Western Australia

  • Royal Melbourne Hospital (RMH)

    Parkville, Victoria

  • Gold Coast Memory Disorders Clinic

    Southport, Quennsland

  • St Vincent Hospital Sydney

    Sydney, New South Wales

  • University of Sydney

    Sydney, New South Wales

Other trials in Australia

United Kingdom16 sites

  • MAC Clinical Research

    Barnsley

  • Cognition Health

    Birmingham

  • MAC Clinical Research

    Blackpool

  • MAC Clinical Research

    Cannock

  • University of Edinburgh

    Edinburgh, Scotland

  • Glasgow Memory Clinic

    Glasgow, Scotland

  • Cognition Health

    Guildford, Surrey

  • MAC Clinical Research

    Leeds

  • MAC Clinical Research

    Liverpool

  • Cognition Health

    London

  • Imperial College

    London

  • King's College

    London

  • MAC Clinical Research

    Manchester

  • Cognition Health

    Plymouth

  • Southern Health NHS Foundation Trust

    Southampton

  • MAC Clinical Research

    Teesside, County Teesside

Other trials in United Kingdom

Canada11 sites

  • Healthy Brain Aging Labs Uni of Calgary

    Calgary, Alberta

  • True North Clinical Research

    Halifax, Nova Scotia

  • True North Clinical Research

    Kentville, Nova Scotia

  • Parkwood Institute

    London, Ontario

  • Bruyere Continuing Care

    Ottawa, Ontario

  • Kawartha Centre

    Peterborough, Ontario

  • Bay Crest Health Sciences

    Toronto, Ontario

  • Toronto Memory Program

    Toronto, Ontario

  • Toronto Western Hospital

    Toronto, Ontario

  • University of British Columbia Hospital

    Vancouver, British Columbia

  • Vancouver Island Health Authority

    Victoria, British Columbia

Other trials in Canada

Germany8 sites

  • Bayreuth Clinic, Hohe Warte Hospital

    Bayreuth, Bavaria

  • Charite University Medicine

    Berlin

  • University Hospital, Bonn

    Bonn, North Rhine-Westphalia

  • Goettingen University Medicine, Clinic for Psychiatry and Psychotherapy

    Göttingen, Lower Saxony

  • Clinic for Psychiatry and Psychotherapy

    Mainz, Rhineland-Palatinate

  • Central Institute of Mental Health

    Mannheim, Hesse

  • Technical University of Munich, School of Medicine

    München, Bavaria

  • University of Ulm, Memory Clinic

    Ulm, Baden-Wurttemberg

Other trials in Germany

Netherlands3 sites

  • Brain Research Center

    's-Hertogenbosch

  • Brain Research Center

    Amsterdam

  • Brain Research Center

    Zwolle

Other trials in Netherlands

About this study

Official title: A Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled 48-week Safety and Efficacy Trial of ANAVEX2-73 for the Treatment of Early Alzheimer's Disease (AD)

Phase 2b/3 48-week study to evaluate the effects of ANAVEX2-73 on cognition and function after 48 weeks of daily treatment. Additional outcome measures include refined measures of sleep, behavioral and psychological symptoms typically observed in AD, changes in daily functioning of participants and changes in caregiver burden, as well as changes in quality of life measures of both, patients and caregivers during treatment with ANAVEX2-73.

Read the detailed description

This is a Phase 2b/3 48-week study to evaluate the effects of ANAVEX2-73 on cognition and function after 48 weeks of daily treatment. Additional outcome measures include refined measures of sleep, behavioral and psychological symptoms typically observed in AD, changes in daily functioning of participants and changes in caregiver burden, as well as changes in quality of life measures of both, patients and caregivers during treatment with ANAVEX2-73. In addition, safety assessments, pharmacokinetic (PK) assessments and collections of CSF and blood markers of AD pathophysiology before and after treatment will be performed.

Being tested
High dose ANAVEX2-73, Mid dose ANAVEX2-73, Placebo oral capsule
Medical subject headings
Alzheimer Disease

What participants receive

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

  • High dose ANAVEX2-73Drug

    Oral capsule

  • Mid dose ANAVEX2-73Drug

    Oral capsule

  • Placebo oral capsuleDrug

    Oral capsule

Study groups in NCT03790709
Study groupRoleWhat they receive
High dose ANAVEX2-73ExperimentalHigh dose active once daily orally
Receives: Drug: High dose ANAVEX2-73
Mid dose ANAVEX2-73ExperimentalMid dose active once daily orally
Receives: Drug: Mid dose ANAVEX2-73
Placebo oral capsulePlacebo comparatorPlacebo dose once daily orally
Receives: Drug: Placebo oral capsule

What is being measured

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

  1. ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition)

    Reduction in cognitive decline assessed from baseline over 48 weeks with ANAVEX2-73 compared to placebo using the Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog)

    Measured: 48 weeks

  2. ADCS-ADL (Activities of Daily Living)

    Reduction in decline of the ability to perform daily activities assessed from baseline over 48 weeks with ANAVEX2-73 compared to placebo using the Activities of Daily Living Scale (ADCS-ADL)

    Measured: 48 weeks

Secondary outcomes (2)

  1. CDR-SB (Clinical Dementia Rating Scale Sum of Boxes)

    Reduction in cognitive decline assessed from baseline over 48 weeks with ANAVEX2-73 compared with placebo using the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)

    Measured: 48 weeks

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

    Assess the safety and tolerability of ANAVEX2-73 compared to placebo

    Measured: 48 weeks

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 start3 Jul 2018
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized 1:1:1 to two different ANAVEX2-73 doses or placebo
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
509 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03790709
Sponsor's protocol ID
ANAVEX2-73-AD-004
Status last verified
Jul 2022
First submitted
24 Dec 2018
Last updated
14 Jul 2022
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 2/3 study testing High dose ANAVEX2-73 and Mid dose ANAVEX2-73 in people with Alzheimer Disease, run by Anavex Life Sciences Corp. at 54 sites in 5 countries.

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 10 inclusion and 27 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: finished, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in Australia, United Kingdom, Canada, Germany, Netherlands. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (Alzheimer Disease Assessment Scale-Cognition) (time frame: 48 weeks). 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 NCT03790709.

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 14 Jul 2022.

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