Prospective 24-week, double-blind, randomised, placebo-controlled, multicentre study evaluating safety and change in efficacy-related surrogate parameters in patients with dementia of the Alzheimer?s type under treatment with increasing dosages of intravenous immunoglobulin (Octagam® 10%)

Phase 2

Completed

• Conditions: Alzheimer's disease (mild to moderate); Nervous System Diseases; Alzheimer's disease

• Registration Number: ISRCTN64846759
• Lead Sponsor: Octapharma AG (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-28
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. Probable Alzheimer's disease (AD) according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
2. Written informed consent by patient or, for significantly cognitively impaired individuals, their legally authorised representative
3. Aged greater than or equal to 50 and less than or equal to 85 years, either sex
4. Mini-mental State Examination (MMSE) greater than or equal to 16 and less than or equal to 26
5. Only for Germany: the patient's capacity to consent has to be confirmed by dated signature on the informed consent form by a second independent investigator who is otherwise not involved in study GAM10-04
6. Modified Hachinski-Rosen Score less than 5
7. Magnetic resonance imaging (MRI) of the head consistent with the diagnosis of AD

Exclusion Criteria

1. Other causes of dementia (e.g. vascular dementia, Lewy Body dementia, fronto-temporal dementia, Creutzfeld-Jacob disease, Huntington's disease, Parkinson's disease)
2. History of or present significant other diseases of the central nervous system (e.g. brain tumour, normal pressure hydrocephalus, stroke, severe brain trauma, brain surgery, epilepsy, encephalitis)
3. Geriatric depression scale of greater than 7 (short form with scale from 0 to 15)
4. Present significant psychiatric disorder (e.g. major depression)
5. History of psychosis or hallucinations
6. Mental retardation
7. Unstable medical disease in the opinion of the investigator
8. Insulin dependent diabetes mellitus
9. Acute infectious disease
10. Uncontrolled hypertension (diastolic blood pressure [BP] greater than 90 mmHg or systolic BP greater than 160 mmHg; sitting)
11. Symptomatic stroke
12. Transient ischaemic attack (TIA) within preceding 2 years
13. Participation in other drug trial currently or within the previous 3 months before screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified