CompletedPhase 2Results posted

Study of Octagam (Intravenous Immunoglobulin [IVIG]) 10% on the Treatment of Mild to Moderate Alzheimer's Disease

Prospective 24-week, Double-blind, Randomised, Placebo-controlled, Multicenter 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%)

Lead sponsor

Octapharma

Asset

Immunoglobulin

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 16-26

Primary endpoint

•The Area Under the Curve of Plasma Aβ1-40 in the 2 or 4 Weeks After the Last

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDGAM10-04

NCT IDNCT00812565

Timeline

Milestones

Study first posted2008-12-22estimated

Study start2009-02 (month precision)

Primary completion2010-09actual (month precision)

Study completion2010-09actual (month precision)

Last update posted2014-05-05estimated

Results first posted2014-05-05estimated

Assets

Drug assets

Immunoglobulin

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.

•Age of 50 to 85.

•Mini-mental State Examination (MMSE) score of 16 to 26.

•Sufficient language skills for testing.

•Sufficient vision and hearing for testing.

•Modified Hachinski-Rosen Score < 5.

•Magnetic resonance imaging (MRI) of the head consistent with the diagnosis of AD.

•Caregiver available with contact at least 4 days per week for greater than 1 hour.

•Outpatient status or assisted living.

•Post-menopause (women) as evidenced by lack of menstruation for at least 12 consecutive months or by having bilateral oophorectomy.

•Stable doses of approved AD medication(s) for at least 3 months prior to screening (eg, acetylcholine esterase (AChE) inhibitors, memantine).

•Normal vital signs or clinically insignificant, if outside normal limits.

•Laboratory findings within normal limits or clinically insignificant, if outside normal limits.

•Normal electrocardiogram (ECG) or clinically not significant, if outside normal limits

Exclusion criteria

•Other causes of dementia (eg, vascular dementia, Lewy-body dementia, fronto-temporal dementia, Creutzfeldt-Jacob disease, Huntington's disease, Parkinson's disease).

•History of or present significant other diseases of the central nervous system (eg, brain tumor, normal pressure hydrocephalus, Parkinson's Disease, stroke, severe brain trauma, brain surgery, epilepsy, encephalitis).

•Geriatric depression scale score > 7 (short form with scale from 0 to 15).

•Present significant psychiatric disorder (eg, major depression).

•History of psychosis or hallucinations.

•Mental retardation.

•Unstable medical disease in the opinion of the investigator.

•Insulin dependent diabetes mellitus.

•Acute infectious disease.

•Vitamin B12 deficiency unless on stable replacement therapy for at least 3 months is acceptable.

•Unstable thyroid dysfunction.

•Uncontrolled hypertension.

•Severe liver or kidney disease.

•Major surgery within 3 months prior to screening.

•Prohibited medications: Antiepileptic drugs, antipsychotics (but allowed for treatment of acute episodes), antiparkinson agents, anticholinergic drugs, selegiline, monoamine oxidase inhibitors (MAOI), tricyclics, immunosuppressive medications, anti-histamines (unless on a stable dose for at least 3 months or used for treatment of acute episodes), benzodiazepines (but allowed for treatment of acute episodes), and lithium.

•Antidepressants are permitted, if on a stable dose for at least 3 months and without significant anticholinergic side-effects.

•Peripheral venous conditions which impair establishing regular venous access for infusions.

•Potential reasons that patient may become non-evaluable during the study (eg, planned moving into a nursing home, but assisted living is acceptable).

•Peripheral venous conditions, which impair establishing regular venous access for infusions.

•Known IgA deficiency with antibodies to IgA.

•History of hypersensitivity to blood or plasma derived products, or any component of octagam 10%, such as maltose.

•Medical conditions which interfere with protein catabolism (eg, nephrotic syndrome).

•Known blood hyperviscosity or other hypercoagulable states.

•Deep vein thrombosis within preceding 4 years.

•Symptomatic stroke.

•Transient ischemic attack (TIA) within preceding 2 years.

•Participation in another drug trial within the previous 3 months before screening.

•Participation in immunological treatment studies of AD other than with intravenous immunoglobulin (IGIV) within the previous 6 months before screening.

•IGIV use in the previous 6 months.

•Live viral vaccination within the last month before study entry.

•Not eligible for lumbar puncture (anticoagulant therapy, coagulation disorders, severe spinal alterations).

•Patients with a past or present history of drug abuse or alcohol abuse within the preceding 5 years.

•Patients with any condition that would make the patient, in the opinion of the Investigator, unsuitable for the study.

Endpoints (28)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Amyloid biomarkers

Global cognition

Other (unclassified)

Function / daily living

Tau biomarkers

Neuroimaging

Safety / tolerability / PK

Global cognition

6 endpoints

Secondary/protocol endpoint

Change From Baseline in the Mini Mental Status Examination (MMSE) Score at Week 12 and Week 24

Time frame:Baseline to Week 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the Alzheimer's Disease Assessment Scale, Cognitive Part (ADAS Cog) Score at Week 12 and Week 24

Time frame:Baseline to Week 24

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the Clinical Dementia Ratio, Sum of Boxes (CDR-SOB) Score at Week 12 and Week 24

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Mini Mental Status Examination (MMSE) Score at Week 12 and Week 24

Time frame:Baseline to Week 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard deviation
Placebo Every 2 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=7 Participants	1.5	2.1
Week 24 (n=7,6,7,6,6,6,8,6)n=7 Participants	-0.7	3.0
0.1 g/kg Octagam 10% Every 2 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=6 Participants	-2.3	3.5
Week 24 (n=7,6,7,6,6,6,8,6)n=6 Participants	-2.2	4.4
0.25 g/kg Octagam 10% Every 2 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=7 Participants	-0.6	3.0
Week 24 (n=7,6,7,6,6,6,8,6)n=7 Participants	0.6	2.5
0.4 g/kg Octagam 10% Every 2 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=6 Participants	-2.0	3.1
Week 24 (n=7,6,7,6,6,6,8,6)n=6 Participants	-1.7	2.3
Placebo Every 4 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=7 Participants	-0.7	3.0
Week 24 (n=7,6,7,6,6,6,8,6)n=7 Participants	-1.8	5.5
0.2 g/kg Octagam 10% Every 4 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=6 Participants	-1.2	2.3
Week 24 (n=7,6,7,6,6,6,8,6)n=6 Participants	-3.2	3.3
0.5 g/kg Octagam 10% Every 4 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=8 Participants	-0.3	2.8
Week 24 (n=7,6,7,6,6,6,8,6)n=8 Participants	-1.8	1.8
0.8 g/kg Octagam 10% Every 4 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=7 Participants	-0.9	2.4
Week 24 (n=7,6,7,6,6,6,8,6)n=7 Participants	-1.5	3.1

Secondary/registry result

Change From Baseline in the Alzheimer's Disease Assessment Scale, Cognitive Part (ADAS Cog) Score at Week 12 and Week 24

Time frame:Baseline to Week 24

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard deviation
Placebo Every 2 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=7 Participants	1.11	4.10
Week 24 (n=7,6,7,6,5,6,8,6)n=7 Participants	-0.62	3.86
0.1 g/kg Octagam 10% Every 2 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=6 Participants	0.94	7.27
Week 24 (n=7,6,7,6,5,6,8,6)n=6 Participants	2.06	3.32
0.25 g/kg Octagam 10% Every 2 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=7 Participants	-0.86	4.75
Week 24 (n=7,6,7,6,5,6,8,6)n=7 Participants	-2.14	4.41
0.4 g/kg Octagam 10% Every 2 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=6 Participants	-0.07	4.43
Week 24 (n=7,6,7,6,5,6,8,6)n=6 Participants	3.67	4.85
Placebo Every 4 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=7 Participants	1.52	5.67
Week 24 (n=7,6,7,6,5,6,8,6)n=7 Participants	0.93	3.29
0.2 g/kg Octagam 10% Every 4 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=6 Participants	3.67	3.85
Week 24 (n=7,6,7,6,5,6,8,6)n=6 Participants	4.17	4.85
0.5 g/kg Octagam 10% Every 4 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=8 Participants	1.54	6.63
Week 24 (n=7,6,7,6,5,6,8,6)n=8 Participants	3.00	9.37
0.8 g/kg Octagam 10% Every 4 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=7 Participants	2.28	5.06
Week 24 (n=7,6,7,6,5,6,8,6)n=7 Participants	1.89	8.71

Secondary/registry result

Change From Baseline in the Clinical Dementia Ratio, Sum of Boxes (CDR-SOB) Score at Week 12 and Week 24

Time frame:Baseline to Week 24

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard deviation
Placebo Every 2 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=7 Participants	-0.67	1.08
Week 24 (n=7,6,7,6,5,6,8,6)n=7 Participants	-0.57	1.57
0.1 g/kg Octagam 10% Every 2 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=6 Participants	-0.25	0.76
Week 24 (n=7,6,7,6,5,6,8,6)n=6 Participants	0.92	2.15
0.25 g/kg Octagam 10% Every 2 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=7 Participants	0.21	0.86
Week 24 (n=7,6,7,6,5,6,8,6)n=7 Participants	0.14	1.28
0.4 g/kg Octagam 10% Every 2 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=6 Participants	0.60	0.89
Week 24 (n=7,6,7,6,5,6,8,6)n=6 Participants	1.25	1.97
Placebo Every 4 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=7 Participants	-0.36	1.38
Week 24 (n=7,6,7,6,5,6,8,6)n=7 Participants	-1.50	2.55
0.2 g/kg Octagam 10% Every 4 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=6 Participants	0.42	1.36
Week 24 (n=7,6,7,6,5,6,8,6)n=6 Participants	0.83	1.44
0.5 g/kg Octagam 10% Every 4 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=8 Participants	0.50	1.46
Week 24 (n=7,6,7,6,5,6,8,6)n=8 Participants	0.44	1.92
0.8 g/kg Octagam 10% Every 4 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=7 Participants	0.21	1.52
Week 24 (n=7,6,7,6,5,6,8,6)n=7 Participants	0.58	1.66

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADAS-ADL) Score at Week 12 and Week 24

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADAS-ADL) Score at Week 12 and Week 24

Time frame:Baseline to Week 24

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard deviation
Placebo Every 2 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=7 Participants	6.7	4.0
Week 24 (n=7,6,7,6,5,6,8,6)n=7 Participants	1.9	5.0
0.1 g/kg Octagam 10% Every 2 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=6 Participants	0.0	5.4
Week 24 (n=7,6,7,6,5,6,8,6)n=6 Participants	-1.5	5.2
0.25 g/kg Octagam 10% Every 2 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=7 Participants	1.7	2.8
Week 24 (n=7,6,7,6,5,6,8,6)n=7 Participants	-4.1	6.6
0.4 g/kg Octagam 10% Every 2 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=6 Participants	-1.2	3.5
Week 24 (n=7,6,7,6,5,6,8,6)n=6 Participants	-6.5	9.7
Placebo Every 4 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=7 Participants	-0.6	8.5
Week 24 (n=7,6,7,6,5,6,8,6)n=7 Participants	-1.8	6.0
0.2 g/kg Octagam 10% Every 4 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=6 Participants	-8.2	11.8
Week 24 (n=7,6,7,6,5,6,8,6)n=6 Participants	-4.3	14.4
0.5 g/kg Octagam 10% Every 4 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=8 Participants	1.8	5.0
Week 24 (n=7,6,7,6,5,6,8,6)n=8 Participants	1.5	8.2
0.8 g/kg Octagam 10% Every 4 WeeksWeek 12 (n=6,6,7,5,7,6,8,7)n=7 Participants	-1.9	3.5
Week 24 (n=7,6,7,6,5,6,8,6)n=7 Participants	-1.2	3.3

Amyloid biomarkers

8 endpoints

Primary/protocol endpoint

Change in the Area Under the Curve of Plasma Aβ1-40 in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion

Time frame:Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks

change from baseline, improvement

Primary/registry result

Change in the Area Under the Curve of Plasma Aβ1-40 in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion

Time frame:Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks

change from baseline, improvement

Posted result

Group	Value (mean), (pg/mL)*days	Standard deviation
Placebo Every 2 Weeksn=5 Participants	161.20	93.90
0.1 g/kg Octagam 10% Every 2 Weeksn=6 Participants	-245.67	747.58
0.25 g/kg Octagam 10% Every 2 Weeksn=7 Participants	-122.50	478.31
0.4 g/kg Octagam 10% Every 2 Weeksn=5 Participants	-39.10	172.72
Placebo Every 4 Weeksn=6 Participants	510.92	2395.80
0.2 g/kg Octagam 10% Every 4 Weeksn=6 Participants	-83.67	957.69
0.5 g/kg Octagam 10% Every 4 Weeksn=8 Participants	-755.38	2232.87
0.8 g/kg Octagam 10% Every 4 Weeksn=6 Participants	-262.92	671.37

Secondary/protocol endpoint

Change in Plasma Concentration of Aβ1-40 and Aβ1-42 From Baseline to the End of the Study (Week 24)

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change in the Area Under the Curve of Plasma Aβ1-42 in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion

Time frame:Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Aβ1-40 and Aβ1-42 in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion

Time frame:Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks

change from baseline, improvement

Secondary/registry result

Change in Plasma Concentration of Aβ1-40 and Aβ1-42 From Baseline to the End of the Study (Week 24)

Time frame:Baseline to Week 24

change from baseline, improvement

Posted result

Group	Value (mean), pg/mL	Standard deviation
Placebo Every 2 WeeksAβ1-40n=7 Participants	27.1	40.2
Aβ1-42n=7 Participants	4.1	3.8
0.1 g/kg Octagam 10% Every 2 WeeksAβ1-40n=6 Participants	5.5	64.5
Aβ1-42n=6 Participants	-2.3	7.8
0.25 g/kg Octagam 10% Every 2 WeeksAβ1-40n=6 Participants	-0.3	22.1
Aβ1-42n=6 Participants	-4.5	6.3
0.4 g/kg Octagam 10% Every 2 WeeksAβ1-40n=6 Participants	-6.5	61.4
Aβ1-42n=6 Participants	-2.7	7.6
Placebo Every 4 WeeksAβ1-40n=6 Participants	-6.0	23.8
Aβ1-42n=6 Participants	-2.0	4.8
0.2 g/kg Octagam 10% Every 4 WeeksAβ1-40n=6 Participants	-20.3	29.2
Aβ1-42n=6 Participants	-3.5	5.8
0.5 g/kg Octagam 10% Every 4 WeeksAβ1-40n=7 Participants	15.7	29.7
Aβ1-42n=7 Participants	-0.1	4.4
0.8 g/kg Octagam 10% Every 4 WeeksAβ1-40n=6 Participants	-30.5	42.3
Aβ1-42n=6 Participants	-7.0	6.2

Secondary/registry result

Change in the Area Under the Curve of Plasma Aβ1-42 in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion

Time frame:Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks

change from baseline, improvement

Posted result

Group	Value (mean), (pg/mL)*days	Standard deviation
Placebo Every 2 Weeksn=5 Participants	40.70	48.54
0.1 g/kg Octagam 10% Every 2 Weeksn=6 Participants	-8.92	61.71
0.25 g/kg Octagam 10% Every 2 Weeksn=7 Participants	-53.94	61.59
0.4 g/kg Octagam 10% Every 2 Weeksn=5 Participants	-17.00	23.67
Placebo Every 4 Weeksn=6 Participants	50.13	233.87
0.2 g/kg Octagam 10% Every 4 Weeksn=6 Participants	-8.98	213.29
0.5 g/kg Octagam 10% Every 4 Weeksn=8 Participants	-191.58	456.83
0.8 g/kg Octagam 10% Every 4 Weeksn=6 Participants	-64.75	148.29

Secondary/registry result

Change From Baseline in Aβ1-40 and Aβ1-42 in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion

Time frame:Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks

change from baseline, improvement

Posted result

Group	Value (mean), pg/mL	Standard deviation
Placebo Every 2 WeeksAβ1-40n=5 Participants	939.4	1670.8
Aβ1-42n=5 Participants	32.4	67.0
0.1 g/kg Octagam 10% Every 2 WeeksAβ1-40n=6 Participants	266.7	996.0
Aβ1-42n=6 Participants	-8.7	38.2
0.25 g/kg Octagam 10% Every 2 WeeksAβ1-40n=7 Participants	10.6	1104.0
Aβ1-42n=7 Participants	9.7	54.7
0.4 g/kg Octagam 10% Every 2 WeeksAβ1-40n=5 Participants	-147.0	1067.9
Aβ1-42n=5 Participants	4.0	40.3
Placebo Every 4 WeeksAβ1-40n=6 Participants	42.0	874.0
Aβ1-42n=6 Participants	-5.2	36.3
0.2 g/kg Octagam 10% Every 4 WeeksAβ1-40n=6 Participants	561.7	1195.5
Aβ1-42n=6 Participants	18.8	40.3
0.5 g/kg Octagam 10% Every 4 WeeksAβ1-40n=8 Participants	403.9	588.1
Aβ1-42n=8 Participants	10.5	40.9
0.8 g/kg Octagam 10% Every 4 WeeksAβ1-40n=6 Participants	642.2	1171.3
Aβ1-42n=6 Participants	24.7	43.2

Tau biomarkers

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Tau and Phosphorylated Tau in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion

Time frame:Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks

Phosphorylated tau 181 (p-tau181)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Tau and Phosphorylated Tau in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion

Time frame:Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks

Phosphorylated tau 181 (p-tau181)

change from baseline, improvement

Posted result

Group	Value (mean), pg/mL	Standard deviation
Placebo Every 2 WeeksTaun=5 Participants	17.4	38.6
Phosphorylated taun=5 Participants	0.60	7.50
0.1 g/kg Octagam 10% Every 2 WeeksTaun=6 Participants	209.3	416.0
Phosphorylated taun=6 Participants	-3.17	14.66
0.25 g/kg Octagam 10% Every 2 WeeksTaun=7 Participants	-3.4	35.6
Phosphorylated taun=7 Participants	0.43	3.60
0.4 g/kg Octagam 10% Every 2 WeeksTaun=5 Participants	-7.8	51.3
Phosphorylated taun=5 Participants	2.60	4.98
Placebo Every 4 WeeksTaun=6 Participants	-33.2	69.7
Phosphorylated taun=6 Participants	-1.33	10.05
0.2 g/kg Octagam 10% Every 4 WeeksTaun=6 Participants	-141.8	419.5
Phosphorylated taun=6 Participants	3.33	21.23
0.5 g/kg Octagam 10% Every 4 WeeksTaun=8 Participants	1.3	86.7
Phosphorylated taun=8 Participants	-2.50	8.62
0.8 g/kg Octagam 10% Every 4 WeeksTaun=6 Participants	131.3	301.0
Phosphorylated taun=6 Participants	10.17	19.28

Neuroimaging

2 endpoints

Secondary/protocol endpoint

Change From Screening in Whole Brain and Hippocampal Volume at Week 12 and Week 24

Time frame:Screening to Week 24

descriptive

Secondary/registry result

Change From Screening in Whole Brain and Hippocampal Volume at Week 12 and Week 24

Time frame:Screening to Week 24

descriptive

Posted result

Group	Value (mean), cm^3	Standard deviation
Placebo Every 2 WeeksWhole brain - Week 12 (n=5,5,7,4,7,6,7,7)n=5 Participants	-0.112	0.738
Left hippocampus - Week 12 (n=5,6,7,5,7,6,7,7)n=5 Participants	-4.3	2.7
Right hippocampus - Week 12 (n=5,6,7,5,7,6,7,7)n=5 Participants	-3.8	2.7
Whole brain - Week 24 (n=4,5,6,5,4,6,8,6)n=5 Participants	-1.403	0.978
Left hippocampus - Week 24 (n=4,6,6,5,5,6,8,6)n=5 Participants	-7.6	3.8
Right hippocampus - Week 24 (n=4,6,6,5,5,6,8,6)n=5 Participants	-7.3	1.2
0.1 g/kg Octagam 10% Every 2 WeeksWhole brain - Week 12 (n=5,5,7,4,7,6,7,7)n=6 Participants	-0.548	1.001
Left hippocampus - Week 12 (n=5,6,7,5,7,6,7,7)n=6 Participants	-3.1	3.1
Right hippocampus - Week 12 (n=5,6,7,5,7,6,7,7)n=6 Participants	-2.6	3.8
Whole brain - Week 24 (n=4,5,6,5,4,6,8,6)n=6 Participants	-1.978	0.798
Left hippocampus - Week 24 (n=4,6,6,5,5,6,8,6)n=6 Participants	-6.6	3.0
Right hippocampus - Week 24 (n=4,6,6,5,5,6,8,6)n=6 Participants	-4.4	4.7
0.25 g/kg Octagam 10% Every 2 WeeksWhole brain - Week 12 (n=5,5,7,4,7,6,7,7)n=7 Participants	-0.709	1.026
Left hippocampus - Week 12 (n=5,6,7,5,7,6,7,7)n=7 Participants	-2.4	1.7
Right hippocampus - Week 12 (n=5,6,7,5,7,6,7,7)n=7 Participants	-3.6	2.6
Whole brain - Week 24 (n=4,5,6,5,4,6,8,6)n=7 Participants	-1.488	0.726
Left hippocampus - Week 24 (n=4,6,6,5,5,6,8,6)n=7 Participants	-6.0	2.8
Right hippocampus - Week 24 (n=4,6,6,5,5,6,8,6)n=7 Participants	-6.3	5.6
0.4 g/kg Octagam 10% Every 2 WeeksWhole brain - Week 12 (n=5,5,7,4,7,6,7,7)n=5 Participants	-1.833	2.001
Left hippocampus - Week 12 (n=5,6,7,5,7,6,7,7)n=5 Participants	-1.8	4.2
Right hippocampus - Week 12 (n=5,6,7,5,7,6,7,7)n=5 Participants	-3.0	2.4
Whole brain - Week 24 (n=4,5,6,5,4,6,8,6)n=5 Participants	-1.390	1.678
Left hippocampus - Week 24 (n=4,6,6,5,5,6,8,6)n=5 Participants	-5.2	4.1
Right hippocampus - Week 24 (n=4,6,6,5,5,6,8,6)n=5 Participants	-4.5	7.1
Placebo Every 4 WeeksWhole brain - Week 12 (n=5,5,7,4,7,6,7,7)n=7 Participants	0.533	0.481
Left hippocampus - Week 12 (n=5,6,7,5,7,6,7,7)n=7 Participants	-2.8	2.6
Right hippocampus - Week 12 (n=5,6,7,5,7,6,7,7)n=7 Participants	-4.8	4.2
Whole brain - Week 24 (n=4,5,6,5,4,6,8,6)n=7 Participants	-0.875	0.780
Left hippocampus - Week 24 (n=4,6,6,5,5,6,8,6)n=7 Participants	-6.0	5.0
Right hippocampus - Week 24 (n=4,6,6,5,5,6,8,6)n=7 Participants	-5.1	4.5
0.2 g/kg Octagam 10% Every 4 WeeksWhole brain - Week 12 (n=5,5,7,4,7,6,7,7)n=6 Participants	-0.528	1.873
Left hippocampus - Week 12 (n=5,6,7,5,7,6,7,7)n=6 Participants	-2.8	3.9
Right hippocampus - Week 12 (n=5,6,7,5,7,6,7,7)n=6 Participants	-1.8	1.6
Whole brain - Week 24 (n=4,5,6,5,4,6,8,6)n=6 Participants	-1.363	1.752
Left hippocampus - Week 24 (n=4,6,6,5,5,6,8,6)n=6 Participants	-7.4	4.3
Right hippocampus - Week 24 (n=4,6,6,5,5,6,8,6)n=6 Participants	-5.3	2.4
0.5 g/kg Octagam 10% Every 4 WeeksWhole brain - Week 12 (n=5,5,7,4,7,6,7,7)n=8 Participants	-0.177	1.219
Left hippocampus - Week 12 (n=5,6,7,5,7,6,7,7)n=8 Participants	-4.8	5.0
Right hippocampus - Week 12 (n=5,6,7,5,7,6,7,7)n=8 Participants	-1.5	3.6
Whole brain - Week 24 (n=4,5,6,5,4,6,8,6)n=8 Participants	-1.096	1.004
Left hippocampus - Week 24 (n=4,6,6,5,5,6,8,6)n=8 Participants	-6.9	7.7
Right hippocampus - Week 24 (n=4,6,6,5,5,6,8,6)n=8 Participants	-6.5	4.6
0.8 g/kg Octagam 10% Every 4 WeeksWhole brain - Week 12 (n=5,5,7,4,7,6,7,7)n=7 Participants	-1.109	0.731
Left hippocampus - Week 12 (n=5,6,7,5,7,6,7,7)n=7 Participants	-2.2	3.7
Right hippocampus - Week 12 (n=5,6,7,5,7,6,7,7)n=7 Participants	-4.9	3.2
Whole brain - Week 24 (n=4,5,6,5,4,6,8,6)n=7 Participants	-1.583	1.070
Left hippocampus - Week 24 (n=4,6,6,5,5,6,8,6)n=7 Participants	-6.2	3.7
Right hippocampus - Week 24 (n=4,6,6,5,5,6,8,6)n=7 Participants	-8.2	5.0

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Change in Plasma Concentration of Anti-Aβ Autoantibodies From Baseline to the End of the Study (Week 24)

Time frame:Baseline to Week 24

change from baseline, event

Secondary/registry result

Change in Plasma Concentration of Anti-Aβ Autoantibodies From Baseline to the End of the Study (Week 24)

Time frame:Baseline to Week 24

change from baseline, event

Posted result

Group	Value (mean), RTU	Standard deviation
Placebo Every 2 Weeksn=7 Participants	109.7	284.8
0.1 g/kg Octagam 10% Every 2 Weeksn=6 Participants	74.3	35.0
0.25 g/kg Octagam 10% Every 2 Weeksn=7 Participants	163.9	136.6
0.4 g/kg Octagam 10% Every 2 Weeksn=6 Participants	310.2	193.0
Placebo Every 4 Weeksn=6 Participants	-56.3	58.3
0.2 g/kg Octagam 10% Every 4 Weeksn=6 Participants	96.7	133.7
0.5 g/kg Octagam 10% Every 4 Weeksn=8 Participants	256.6	214.1
0.8 g/kg Octagam 10% Every 4 Weeksn=6 Participants	501.3	514.6

Other (unclassified)

6 endpoints

Secondary/protocol endpoint/low confidence

Change in the Area Under the Curve of Plasma Anti-Aβ Autoantibodies in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion

Time frame:Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Anti-Aβ Autoantibodies in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion

Time frame:Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Left and Right Hippocampal Cerebral Glucose Metabolism at Baseline and at Week 24

Time frame:Baseline to Week 24

descriptive

Secondary/registry result/low confidence

Change in the Area Under the Curve of Plasma Anti-Aβ Autoantibodies in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion

Time frame:Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks

change from baseline, improvement

Posted result

Group	Value (mean), RTU*days	Standard deviation
Placebo Every 2 Weeksn=5 Participants	2829.0	3957.9
0.1 g/kg Octagam 10% Every 2 Weeksn=6 Participants	358.3	435.8
0.25 g/kg Octagam 10% Every 2 Weeksn=7 Participants	1862.5	1470.9
0.4 g/kg Octagam 10% Every 2 Weeksn=5 Participants	2189.6	2289.3
Placebo Every 4 Weeksn=6 Participants	196.6	1023.0
0.2 g/kg Octagam 10% Every 4 Weeksn=6 Participants	849.4	2313.6
0.5 g/kg Octagam 10% Every 4 Weeksn=8 Participants	6350.8	3464.9
0.8 g/kg Octagam 10% Every 4 Weeksn=6 Participants	8494.9	2292.4

Secondary/registry result/low confidence

Change From Baseline in Anti-Aβ Autoantibodies in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion

Time frame:Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks

change from baseline, improvement

Posted result

Group	Value (mean), RTU	Standard deviation
Placebo Every 2 Weeksn=5 Participants	0.38	3.72
0.1 g/kg Octagam 10% Every 2 Weeksn=6 Participants	0.22	1.83
0.25 g/kg Octagam 10% Every 2 Weeksn=7 Participants	1.86	1.93
0.4 g/kg Octagam 10% Every 2 Weeksn=5 Participants	-0.78	1.64
Placebo Every 4 Weeksn=6 Participants	0.15	0.29
0.2 g/kg Octagam 10% Every 4 Weeksn=6 Participants	0.40	1.43
0.5 g/kg Octagam 10% Every 4 Weeksn=8 Participants	1.12	1.48
0.8 g/kg Octagam 10% Every 4 Weeksn=6 Participants	0.74	2.32

Secondary/registry result/low confidence

Left and Right Hippocampal Cerebral Glucose Metabolism at Baseline and at Week 24

Time frame:Baseline to Week 24

descriptive

Posted result

Group	Value (mean), µCi/mL	Standard deviation
Placebo Every 2 WeeksRight hippocampus - Baselinen=7 Participants	0.83	0.06
Right hippocampus - Week 24 (n=6,6,6,5,3,6,8,6)n=7 Participants	0.84	0.07
Left hippocampus - Baselinen=7 Participants	0.79	0.05
Left hippocampus - Week 24 (n=6,6,6,5,3,6,8,6)n=7 Participants	0.80	0.03
0.1 g/kg Octagam 10% Every 2 WeeksRight hippocampus - Baselinen=6 Participants	0.81	0.06
Right hippocampus - Week 24 (n=6,6,6,5,3,6,8,6)n=6 Participants	0.83	0.07
Left hippocampus - Baselinen=6 Participants	0.77	0.06
Left hippocampus - Week 24 (n=6,6,6,5,3,6,8,6)n=6 Participants	0.78	0.05
0.25 g/kg Octagam 10% Every 2 WeeksRight hippocampus - Baselinen=6 Participants	0.81	0.06
Right hippocampus - Week 24 (n=6,6,6,5,3,6,8,6)n=6 Participants	0.83	0.06
Left hippocampus - Baselinen=6 Participants	0.80	0.07
Left hippocampus - Week 24 (n=6,6,6,5,3,6,8,6)n=6 Participants	0.84	0.09
0.4 g/kg Octagam 10% Every 2 WeeksRight hippocampus - Baselinen=6 Participants	0.83	0.06
Right hippocampus - Week 24 (n=6,6,6,5,3,6,8,6)n=6 Participants	0.81	0.02
Left hippocampus - Baselinen=6 Participants	0.81	0.05
Left hippocampus - Week 24 (n=6,6,6,5,3,6,8,6)n=6 Participants	0.80	0.07
Placebo Every 4 WeeksRight hippocampus - Baselinen=6 Participants	0.81	0.08
Right hippocampus - Week 24 (n=6,6,6,5,3,6,8,6)n=6 Participants	0.82	0.07
Left hippocampus - Baselinen=6 Participants	0.81	0.07
Left hippocampus - Week 24 (n=6,6,6,5,3,6,8,6)n=6 Participants	0.81	0.08
0.2 g/kg Octagam 10% Every 4 WeeksRight hippocampus - Baselinen=7 Participants	0.88	0.03
Right hippocampus - Week 24 (n=6,6,6,5,3,6,8,6)n=7 Participants	0.87	0.04
Left hippocampus - Baselinen=7 Participants	0.84	0.05
Left hippocampus - Week 24 (n=6,6,6,5,3,6,8,6)n=7 Participants	0.84	0.05
0.5 g/kg Octagam 10% Every 4 WeeksRight hippocampus - Baselinen=8 Participants	0.82	0.08
Right hippocampus - Week 24 (n=6,6,6,5,3,6,8,6)n=8 Participants	0.84	0.07
Left hippocampus - Baselinen=8 Participants	0.80	0.06
Left hippocampus - Week 24 (n=6,6,6,5,3,6,8,6)n=8 Participants	0.81	0.05
0.8 g/kg Octagam 10% Every 4 WeeksRight hippocampus - Baselinen=7 Participants	0.81	0.04
Right hippocampus - Week 24 (n=6,6,6,5,3,6,8,6)n=7 Participants	0.82	0.03
Left hippocampus - Baselinen=7 Participants	0.77	0.04
Left hippocampus - Week 24 (n=6,6,6,5,3,6,8,6)n=7 Participants	0.79	0.05

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Dodel R, Rominger A, Bartenstein P, Barkhof F, Blennow K, Forster S, Winter Y, Bach JP, Popp J, Alferink J, Wiltfang J, Buerger K, Otto M, Antuono P, Jacoby M, Richter R, Stevens J, Melamed I, Goldstein J, Haag S, Wietek S, Farlow M, Jessen F. Intravenous immunoglobulin for treatment of mild-to-moderate Alzheimer's disease: a phase 2, randomised, double-blind, placebo-controlled, dose-finding trial. Lancet Neurol. 2013 Mar;12(3):233-43. doi: 10.1016/S1474-4422(13)70014-0. Epub 2013 Jan 31.
PMID23375965via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.