An open label extension study to evaluate long term use of a Food for Special Medical Purposes (FSMP) in patients with mild Alzheimer*s disease who completed the Souvenir II study

An open label extension study to evaluate long term use of a Food for Special Medical Purposes (FSMP) in patients with mild Alzheimer*s disease who completed the Souvenir II study - Souvenir II Open Label Extension Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36704

Enrollment

120

Registered

2010-06-08

Start date

2010-10-03

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Alzheimers Disease

Interventions

The study product is a 125ml (125kcal) once-a-day drink to be taken with breakfast. There is a choice of two flavours: vanilla and strawberry.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Completion of 24 week study visit Souvenir II study or the Souvenir II MEG sub-study Availability of responsible caregiver Written informed consent of subject and caregiver

Exclusion criteria

Exclusion criteria: Use of other investigational products Alcohol or drug abuse in opinion of the investigator Uncertainty about willingness, ability, or medical status of subject to comply with protocol requirements

Design outcomes

Primary

Measure	Time frame
Compliance Safety	—

Secondary

Measure	Time frame
Exploratory parameters include: -Cognition -Global function	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)