Alzheimer´s DiseasePhase 3NCT01736579

Long-Term Study of IGIV, 10% in Alzheimer´s Disease

A Phase 3 study testing Immune Globulin Intravenous (Human), 10% (IGIV, 10%) in people with Alzheimer´s Disease, run by Baxalta now part of Shire at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 51 years and older
Conditions the study is for: Alzheimer´s Disease
What is being tested?: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 29 Nov 2012to 4 Jun 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 51 years and older
All sexes
No healthy volunteers
Adult, Older adult

Main Inclusion Criteria:

Completed 18 months of study treatment and assessments in Baxter precursor study 160701
Diagnosis of probable Alzheimer´s Disease (AD)
Able to comply with testing and infusion regimen (including adequate corrected visual acuity and hearing ability)
Has a caregiver (study partner) who is willing and able to participate

Main Exclusion Criteria:

Significant neurological disease other than AD
Clinically significant cardiac/cardiovascular problems (e.g. uncontrolled blood pressure, atrial fibrillation, heart disease, clotting disorders, strokes, or recent heart attack)
Contraindication to undergoing MRI (e.g. pacemaker [with the exception of an MRI-compatible pacemaker], severe claustrophobia, ferromagnetic implants such as a metal plate)
Specific findings on brain MRI (microhemorrhages, superficial siderosis, vasogenic edema, a macrohemorrhage, major stroke, or multiple lacunae)
Active malignancy or history of malignancy within 5 years prior to screening with the exception of the following: adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and stable prostate cancer not requiring treatment
Uncontrolled major depression, psychosis, or other major psychiatric disorder(s)
Poorly controlled diabetes
Serious problems with liver or kidneys
Known history of hypersensitivity following infusions of human blood or blood components (e.g. human immunoglobulins or human albumin)
Current or recent treatment with immunomodulatory therapies (with the exception of immunoglobulin and non-systemic and low-dose systemic corticosteroids)
Recent use of investigational drugs or biologics, including those aimed at altering AD progression (with the exception of immunoglobulin)
Active immunization for the treatment of AD at any time

There are reasons why it might not be appropriate to participate in this trial. Please contact Medical Information at medinfo@baxter.com for details.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Rochester, New York

Other trials in United States

About this study

Official title: A Study of the Long-Term Safety and Efficacy of Immune Globulin Intravenous (Human), 10% Solution (IGIV, 10%) in Mild to Moderate Alzheimer´s Disease

The purpose of this long-term study is to provide additional evidence of safety and efficacy of IGIV, 10% treatment in participants with Alzheimer´s Disease who have completed the Phase 3 Baxter precursor study 160701. All participants will receive IGIV, 10% at either 0.2 g/kg or 0.4 g/kg body weight depending on their treatment assignment in Baxter study 160701. Participants and investigators will be blinded to dose unless otherwise notified by the sponsor.

Conditions: Alzheimer´s Disease
Being tested: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Immune Globulin Intravenous (Human), 10% (IGIV, 10%)Drug
Also called Gammagard Liquid

Study groups in NCT01736579
Study group	Role	What they receive
IGIV, 10% at 0.2 g/kg body weight	Experimental	IGIV, 10% at 0.2 g/kg body weight every 2 weeks for up to 3 years, 6 months. Receives: Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
IGIV, 10% at 0.4 g/kg body weight	Experimental	IGIV, 10% at 0.4 g/kg body weight every 2 weeks for up to 3 years, 6 months Receives: Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number and Severity of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: 6 months
Number of Infusions Temporally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: 6 months
Number of Infusions Causally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: 6 months
Number of Infusions Discontinued, Slowed or Interrupted Due to an Adverse Event (AE) or Serious Adverse Event (SAE)
Measured: 6 months

Secondary outcomes (11)

Total Score of the Cognitive Subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog)
The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer's Disease Cooperative Study (ADCS) at the site. Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment.
Measured: 6 months
Total Score of the Cognitive Subscale of the Severe Impairment Battery (SIB)
The SIB is a 40-item psychometric assessment that is composed of simple one-step commands combined with gestures. The scoring range is from 0 to 100 with a lower score indicating greater cognitive impairment.
Measured: 6 months
Alzheimer's Disease Cooperative Study (ADCS) - Activities of Daily Living (ADL) Inventory (ADCS-ADL/ ADCS-ADL-severe)
The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner. Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration.
Measured: 6 months
Mini Mental State Examination (MMSE)
The MMSE is a test for cognitive dysfunction. The test provides a 30-point composite rating for spatial and temporal orientation, verbal recall, simple attention, working memory, naming, repetition, comprehension, writing and constructional abilities. The total score can range from 0 to 30 with a higher score indicating better function.
Measured: 6 months
Neuropsychiatric Inventory (NPI) Score
The NPI is a validated instrument used to assess behavioral psychopathology in Alzheimer's Disease; it evaluates the frequency and severity of 12 neuropsychiatric features including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behavior change, and appetite and eating change. The NPI total score ranged 0-144, with higher scores indicating greater impairment.
Measured: 6 months
Logsdon Quality of Life in Alzheimer's Disease (QOL-AD)
The QOL-AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant's quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52. Lower scores on the QOL-AD are associated with a lower quality of life.
Measured: 6 months
EQ-5D Questionnaire (Proxy Version)
EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome. The EQ-5D also includes a standard vertical 20 cm visual analogue scale (VAS) ranging from best imaginable health state [100] to worst imaginable health state [0]. Caregivers are asked to describe how they believe a participant would rate his/her health state that day.
Measured: 6 months
Healthcare Resource Utilization Questionnaire (HRUQ)
The HRUQ determines if there is a difference in healthcare utilization and health-related expenditures, most notably nursing home (ie, skilled nursing facility) admissions, when subjects are treated with study product. This assessment is performed with the primary caregiver. This assessment is descriptive and does not contain specific scores.
Measured: 6 months
Caregiver Burden Questionnaire
The Caregiver burden questionnaires is a self-administered questionnaire that has been developed to measure the emotional, physical, and social impact of caregiving on Alzheimer's Disease caregivers. A Total score is calculated from this measure by summing the responses across the items. The Total score may range from 9-45, with higher scores indicating greater burden.
Measured: 6 months
Time to Skilled Nursing Facility Placement
Time to skilled nursing facility placement is defined as permanent admission to a skilled nursing facility. Time will be defined as the number of months between enrollment into this clinical study and placement in a skilled nursing facility placement.
Measured: 6 months
Volumetric MRI
Volumetric MRI measurements were obtained to assess rate of whole brain atrophy and ventricular enlargement. Additional volumetric measurements may be analyzed when specific hypotheses and methods are defined. Additional volumetric MRI analysis may include (but may not be limited to) one or more of the following: rate of hippocampal atrophy, entorhinal cortical thickness, and/or regional cortical thinning.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Nov 20124 Jun 2013

First posted29 Nov 2012 (estimated)
Study start29 Nov 2012
Primary completion4 Jun 2013
Study completion4 Jun 2013

Why it stopped: The study was terminated because the first Phase 3 did not demonstrate efficacy on the co-primary endpoints. The known safety profile remained unchanged.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alzheimer´s DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01736579
Sponsor's protocol ID: 161202
Status last verified: Apr 2021
First submitted: 27 Nov 2012
Last updated: 19 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alzheimer´s Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of the Long-Term Safety and Efficacy of Immune Globulin Intravenous (Human), 10% Solution (IGIV, 10%) in Mild to Moderate Alzheimer´s Disease
ClinicalTrials.gov ID: NCT01736579
Acronym / sponsor ID: 161202
Conditions: Alzheimer´s Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated because the first Phase 3 did not demonstrate efficacy on the co-primary endpoints. The known safety profile remained unchanged.
Enrolment: 6 participants (actual)
Lead sponsor: Baxalta now part of ShireIndustry (pharma, biotech, devices)
Study start: 29 Nov 2012 (actual)
Primary completion: 4 Jun 2013 (actual)
Study completion: 4 Jun 2013 (actual)
First posted: 29 Nov 2012 (estimated)
Results: Posted 23 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
IGIV, 10% at 0.2 g/kg body weight	Experimental	Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)IGIV, 10% at 0.2 g/kg body weight every 2 weeks for up to 3 years, 6 months.
IGIV, 10% at 0.4 g/kg body weight	Experimental	Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)IGIV, 10% at 0.4 g/kg body weight every 2 weeks for up to 3 years, 6 months

Who may qualify

Ages: 51 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Immune Globulin Intravenous (Human), 10% (IGIV, 10%)Also: Gammagard Liquid	Drug	IGIV, 10% at 0.2 g/kg body weight, IGIV, 10% at 0.4 g/kg body weight

Primary outcome

Number and Severity of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 6 months
Number of Infusions Temporally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 6 months
Number of Infusions Causally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 6 months
Number of Infusions Discontinued, Slowed or Interrupted Due to an Adverse Event (AE) or Serious Adverse Event (SAE)
Time frame: 6 months

11 secondary outcomes

Total Score of the Cognitive Subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog)
Time frame: 6 months
Total Score of the Cognitive Subscale of the Severe Impairment Battery (SIB)
Time frame: 6 months
Alzheimer's Disease Cooperative Study (ADCS) - Activities of Daily Living (ADL) Inventory (ADCS-ADL/ ADCS-ADL-severe)
Time frame: 6 months
Mini Mental State Examination (MMSE)
Time frame: 6 months
Neuropsychiatric Inventory (NPI) Score
Time frame: 6 months
Logsdon Quality of Life in Alzheimer's Disease (QOL-AD)
Time frame: 6 months
EQ-5D Questionnaire (Proxy Version)
Time frame: 6 months
Healthcare Resource Utilization Questionnaire (HRUQ)
Time frame: 6 months
Caregiver Burden Questionnaire
Time frame: 6 months
Time to Skilled Nursing Facility Placement
Time frame: 6 months
Volumetric MRI
Time frame: 6 months

Results and safety

Results posted to the registry on 23 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IGIV, 10% at 0.2 g/kg Body Weight	2	0
IGIV, 10% at 0.4 g/kg Body Weight	2	0

Primary outcome: Number and Severity of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: 6 months. Number. Unit: adverse events

Measure	IGIV, 10% at 0.2 g/kg Body Weight n = 2	IGIV, 10% at 0.4 g/kg Body Weight n = 2
Non-serious AEs-Mild	2	0
Non-serious AEs-Moderate	1	1
SAEs	0	0

Primary outcome: Number of Infusions Temporally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: 6 months. Number. Unit: infusions

Measure	IGIV, 10% at 0.2 g/kg Body Weight n = 2	IGIV, 10% at 0.4 g/kg Body Weight n = 2
Value	1	0

Primary outcome: Number of Infusions Causally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: 6 months. Number. Unit: infusions

Measure	IGIV, 10% at 0.2 g/kg Body Weight n = 2	IGIV, 10% at 0.4 g/kg Body Weight n = 2
Value	1	1

Primary outcome: Number of Infusions Discontinued, Slowed or Interrupted Due to an Adverse Event (AE) or Serious Adverse Event (SAE)

Time frame: 6 months. Number. Unit: infusions

Measure	IGIV, 10% at 0.2 g/kg Body Weight n = 2	IGIV, 10% at 0.4 g/kg Body Weight n = 2
Value	0	0

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the study period (6 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IGIV, 10% at 0.2 g/kg Body Weight	0 of 2 (0%)	1 of 2 (50%)	Not reported
IGIV, 10% at 0.4 g/kg Body Weight	0 of 2 (0%)	1 of 2 (50%)	Not reported

Limitations and caveats (from the sponsor): This study was an extension of study 160701 and was stopped early due to lack of evidence of clinical benefit of IGIV treatment in Alzheimer's Disease patients in Baxalta study 160701. Summary tables available for safety data only.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Immune Globulin Intravenous (Human), 10% (IGIV, 10%) in people with Alzheimer´s Disease, run by Baxalta now part of Shire at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and Severity of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01736579.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.