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ATTENTION-AD

CompletedPhase 2 / PHASE3

OLE of Phase 2b/3 Study ANAVEX2-73-AD-004

Open Label Extension Study for Patients With Early Alzheimer's Disease (AD) Enrolled in Study ANAVEX2-73-AD-004

Asset

ANAVEX2-73

Listed sites

51

Recruiting sites

-

Enrollment

300

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Treatment-related adverse events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDANAVEX2-73-AD-EP-004
NCT IDNCT04314934

Timeline

Milestones

Study start2019-10-10actual
Study first posted2020-03-19actual
Primary completion2024-06-14actual
Study completion2024-06-14actual
Last update posted2024-08-12actual

Assets

Drug assets

ANAVEX2-73

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Previous completion of participation in the ANAVEX2-73-AD-004 double-blind study.
•Participants may be either outpatients, or residents of an assisted-living facility.
•Participants must have 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

Exclusion criteria

•Adverse events (AEs) from the previous study (ANAVEX2-73-AD-004) that have not resolved, are moderate or severe, judged to be possibly related or related to study drug, and considered by the investigator to be a contraindication to extension study participation
•Any condition or laboratory abnormality that would make the subject, in the judgment of the investigator, unsuitable for the study
•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)).
•Any known hypersensitivity to any of the excipients contained in the study drug formulation.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition
1
Function / daily living
1
Safety / tolerability / PK
1

Global cognition

1 endpoint
Secondary/protocol endpoint

ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition)

Time frame:96 weeks

ADAS-Cog

change from baseline, improvement

Function / daily living

1 endpoint
Secondary/protocol endpoint

ADCS-ADL (Activities of Daily Living)

Time frame:96 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

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

Time frame:96 weeks

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.