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ANAVEX

CompletedPhase 2

Phase 2a Dose Finding, PK/PD and 12 Month Exploratory Efficacy Study of ANAVEX2-73 in Patients With Alzheimer's Disease

Phase 2a Study of ANAVEX2-73 Adaptive-Trial-Design With Repeated Doses, MTD Finding, Pharmacodynamic and Bioavailability Evaluation in Patients With Mild to Moderate Alzheimer's Disease With a 12-Month Open Label Follow-Up Period

Asset

ANAVEX2-73

Listed sites

5

Recruiting sites

-

Enrollment

32

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 16-28•Study partner/caregiver required

Primary endpoint

•Maximum tolerated dose of Anavex2-73

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 IDANAVEX2-73-002
NCT IDNCT02244541

Timeline

Milestones

Study first posted2014-09-19estimated
Study start2014-12actual (month precision)
Primary completion2015-11actual (month precision)
Study completion2016-11actual (month precision)
Last update posted2018-11-28actual

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

Main Inclusion Criteria:

1. Diagnosis of Probable AD in accordance with NINCDS-ADRDA criteria.

2. A brain CT or MRI scan performed within last 12 months from day of screening consistent with the clinical diagnosis of probable AD.

3. Age from 55 to 85 years inclusive.

4. MMSE score of 16-28 inclusive.

5. Rosen Modified Hachinski Ischemic score <=4.

6. Community dwelling with caregiver who has regular contact with the subject for at least 10 hours per week and is able to oversee the patient's compliance with study medication and participate in the patient's clinical assessment and is capable of accompanying the participant on all clinic visits.

7. Fluency in English.

8. Be able to read, write, speak clearly for the cognitive tests, with eyesight and hearing sufficient to enable completion of the cognitive tests.

9. Receiving stable doses of medications for the treatment of non-excluded medical conditions for at least 30 days prior to screening

Exclusion criteria

1. Dementia other than AD such as AIDS, CJD, LBD, CVD, Progressive Supranuclear Palsy, Multiple cerebral infarcts, or normal pressure hydrocephalus.

2. Other neurodegenerative diseases, including Parkinson's disease and Huntington's disease, or cerebral tumour.

3. Current presence of a clinically significant major psychiatric disorder according to the criteria of the DSM-IV, or symptom that could affect the participant's ability to complete the study). HAM-D score >12.

4. 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.

5. Any other criteria which in the opinion of the Investigator causes the participant not to qualify for the study.

Endpoints (8)

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

Other (unclassified)
4
Global cognition
1
Function / daily living
1
Behavior / neuropsychiatric
1
Fluid / digital biomarkers
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Mini-mental state examination score (MMSE)

Time frame:Baseline, and during the extension period at Week 1, 12, 26, 36, 48, and 52

Mini-Mental State Examination (MMSE)

descriptive

Function / daily living

1 endpoint
Secondary/protocol endpoint

Score from ADCS-ADL (Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory)

Time frame:Baseline, and during the extension period at Week 1, 12, 26, 36, 48, and 52

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Hamilton Psychiatric Rating Scale for Depression (HAM-D) Score

Time frame:Baseline at Period 1

descriptive

Fluid / digital biomarkers

1 endpoint
Secondary/protocol endpoint

Electroencephalographic activity, including event-related potentials (EEG/ERP)

Time frame:baseline, Day 1, 5, 11 of Period 1 and Day 1, 5, 11 of Period 2 and, Week 12, 36, 48, and 52 of the extension period

event count, event

Other (unclassified)

4 endpoints
Primary/protocol endpoint/low confidence

To determine maximum tolerated dose of Anavex2-73.

Time frame:36 Days

descriptive

Secondary/protocol endpoint/low confidence

PK sampling- blood test results

Time frame:First part (PART A), first period (hours): 1, 48, 264; second period (hours): 1, 72, 264; extension period (PART B): Week 1, 12 and 26.

descriptive

Secondary/protocol endpoint/low confidence

Cogstate Brief Battery (CBB) Score and International Shopping List Task (ISLT) Score

Time frame:At baseline, Day 1, 2, 6, 9, 12 of Period 1 and Day 1, 2, 6, 9, 12 of Period 2 and during the extension period at Week 12, 36, 48, and 52.

descriptive

Secondary/protocol endpoint/low confidence

Rosen Modified Hachinski Ischemic Score (RM/HIS10)

Time frame:Baseline at period 1

descriptive

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.