ANAVEX2-73-AD-EP-004
Research type
Research Study
Full title
Open Label Extension Study for Patients with Early Alzheimer’s Disease (AD) Enrolled in Study ANAVEX2-73-AD-004
IRAS ID
304373
Contact name
Dag Aarsland
Contact email
Sponsor organisation
Anavex Germany GmbH
Eudract number
2021-004325-80
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 10 months, 13 days
Research summary
This is a Phase 2b/3 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and cognition after 96 weeks of daily treatment. Additional outcome measures include measures of function and behavioural symptoms typically observed in AD during treatment with ANAVEX2-73.
The study is limited to subjects who completed the ANAVEX2-73-AD-004 double-blind
clinical study who consent to enrol in the open label study.
All patients regardless of their prior dose during the ANAVEX2-73-AD-004
clinical trial will begin treatment at 10 mg/day ANAVEX2-73 for the first two weeks (Week 0 and Week 1), increasing by 10 mg every two weeks over a 10-week period to a maximum maintenance daily dose of either 50 mg/day or best tolerated dose. Then a maintenance period (Weeks 11-96)of 50 mg/day ANAVEX2-73 or best tolerated dose.
Assessments include: 12 Lead ECG, laboratory blood tests, Urine dipstick, questionnaires (ADAS-Cog, ADCS-ADL, MMSE, ZBI, NPI-Q, QoL-AD, C-SSRS).REC name
London - South East Research Ethics Committee
REC reference
21/LO/0730
Date of REC Opinion
21 Dec 2021
REC opinion
Further Information Favourable Opinion