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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02244541




Registration number
NCT02244541
Ethics application status
Date submitted
31/08/2014
Date registered
19/09/2014
Date last updated
28/11/2018

Titles & IDs
Public title
Phase 2a Dose Finding, PK/PD and 12 Month Exploratory Efficacy Study of ANAVEX2-73 in Patients With Alzheimer's Disease
Scientific title
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
Secondary ID [1] 0 0
ANAVEX2-73-002
Universal Trial Number (UTN)
Trial acronym
ANAVEX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ANAVEX2-73 Oral
Treatment: Drugs - ANAVEX2-73 Oral

Experimental: Anavex2-73 oral then the Anavex2-73 intravenous formulation - Participants first receive Anavex2-73 hard gelatin capsule each morning with a light breakfast for 11 days. After a washout period of 11 days they then receive the Anavex2-73 intravenous formulation each morning with a light breakfast for 11 days.

Experimental: Anavex2-73 intravenous then the Anavex2-73 oral formulation - Participants first receive Anavex2-73 intravenous formulation each morning with a light breakfast for 11 days. After a washout period of 11 days then they receive the Anavex2-73 hard gelatin capsule each morning with a light breakfast for 11 days.

Experimental: Anavex2-73 30 mg oral formulation - Participants will receive the 30 mg Anavex2-73 hard gelatin capsule orally once daily for 52 weeks.

Experimental: Anavex2-73 50 mg oral formulation - Participants will receive the 50 mg Anavex2-73 hard gelatin capsule orally once daily for 52 weeks.


Treatment: Drugs: ANAVEX2-73 Oral
30 mg hard gelatin capsule

Treatment: Drugs: ANAVEX2-73 Oral
50 mg hard gelatin capsule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine maximum tolerated dose of Anavex2-73.
Timepoint [1] 0 0
36 Days
Secondary outcome [1] 0 0
PK sampling- blood test results
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
Mini-mental state examination score (MMSE)
Timepoint [2] 0 0
Baseline, and during the extension period at Week 1, 12, 26, 36, 48, and 52
Secondary outcome [3] 0 0
Score from ADCS-ADL (Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory)
Timepoint [3] 0 0
Baseline, and during the extension period at Week 1, 12, 26, 36, 48, and 52
Secondary outcome [4] 0 0
Cogstate Brief Battery (CBB) Score and International Shopping List Task (ISLT) Score
Timepoint [4] 0 0
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.
Secondary outcome [5] 0 0
Electroencephalographic activity, including event-related potentials (EEG/ERP)
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Hamilton Psychiatric Rating Scale for Depression (HAM-D) Score
Timepoint [6] 0 0
Baseline at Period 1
Secondary outcome [7] 0 0
Rosen Modified Hachinski Ischemic Score (RM/HIS10)
Timepoint [7] 0 0
Baseline at period 1

Eligibility
Key inclusion criteria
Main

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.

Main
Minimum age
55 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2016
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Melbourne Health - The Royal Melbourne Hospital - Melbourne
Recruitment hospital [2] 0 0
Austin Health - Heidelberg Repatriation Hospital - Melbourne
Recruitment hospital [3] 0 0
Caulfield Hospital - Melbourne
Recruitment hospital [4] 0 0
Nucleus Network- Centre for Clinical Studies - Melbourne
Recruitment hospital [5] 0 0
St. Vincent's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne
Recruitment postcode(s) [2] 0 0
3084 - Melbourne
Recruitment postcode(s) [3] 0 0
3162 - Melbourne
Recruitment postcode(s) [4] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Anavex Life Sciences Corp.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this Phase 2a study is to evaluate the maximal tolerated dose of ANAVEX2-73 in patients with AD in a repeated-dose administration scheme, with the secondary objectives being to explore the relationship between dosing regimen and pharmacodynamics efficacy outcomes and to evaluate the bioavailability of the oral form used and to explore the relationship of ANAVEX2-73 as add-on therapy to AD standard of care.
Trial website
https://clinicaltrials.gov/study/NCT02244541
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Macfarlane
Address 0 0
Caulfield Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02244541