Souvenir II Open Label Extension 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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26602

Enrollment

200

Registered

2010-10-15

Start date

2010-07-15

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Alzheimer’s Disease

Interventions

Duration of intervention: 24 weeks. Intervention: All participants will receive daily 125 ml of Souvenaid®. Souvenaid® is a 125ml (125kcal) once-a-day milk based drink. Souvenaid® contains FortasynTM

Eligibility

Inclusion criteria

Inclusion criteria: 1. Completion of 24 week study visit Souvenir II study; 2. Availability of responsible caregiver; 3. Written informed consent of subject and caregiver.

Exclusion criteria

Exclusion criteria: 1. Use of other investigational products; 2. Alcohol or drug abuse in opinion of the investigator; 3. Investigator’s uncertainty about willingness, ability, or medical status of subject to comply with protocol requirements.

Design outcomes

Primary

Measure	Time frame
Compliance and safety: 1. Compliance as measured by the daily study product intake and product evaluation on taste and convenience; 2. Safety as measured by the number of (Serious) Adverse Events.	—

Contacts

Public ContactRico L. Wieggers

Danone Research – Centre for Specialised Nutrition PO Box 7005

rico.wieggers@danone.com+31 (0)317 467 800/+31 (0)646 237 293

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)