Trial Outcomes & Findings for Phase II Study of Intravenous Immunoglobulin (IVIg) for Alzheimer's Disease (NCT NCT00299988)

Results Overview

The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is a brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia. It is one of the most widely used cognitive scales in clinical trials and is considered to be the "gold standard" for assessing antidementia treatments. The ADAS-Cog range from 0 to 70, where higher scores indicate greater cognitive dysfunction.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

12 months

Results posted on

2019-12-11

Participant Flow

Participant milestones

Participant milestones
Measure	IVIG ivig Intravenous Immunoglobulin	Placebo
Overall Study STARTED	16	8
Overall Study COMPLETED	16	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study of Intravenous Immunoglobulin (IVIg) for Alzheimer's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IVIG n=16 Participants Intravenous Immunoglobulin	Placebo n=8 Participants placebo	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=93 Participants	8 Participants n=4 Participants	24 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	4 Participants n=4 Participants	13 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	4 Participants n=4 Participants	11 Participants n=27 Participants
Region of Enrollment United States	16 Participants n=93 Participants	8 Participants n=4 Participants	24 Participants n=27 Participants

PRIMARY outcome

Timeframe: 12 months

The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is a brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia. It is one of the most widely used cognitive scales in clinical trials and is considered to be the "gold standard" for assessing antidementia treatments. The ADAS-Cog range from 0 to 70, where higher scores indicate greater cognitive dysfunction.

Outcome measures

Outcome measures
Measure	IVIG n=16 Participants ivig Intravenous Immunoglobulin	Placebo n=8 Participants
ADAS-Cog	NA units on a scale After extensive review of the records the actual calculations of the data cannot be located.	NA units on a scale After extensive review of the records the actual calculations of the data cannot be located.

PRIMARY outcome

Timeframe: 12 months

The Clinical Global Impression of Change focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of informants. Unlike a targeted symptom scale, it takes into account a subject's overall function in the cognitive, behavioral and functional activity domains. Scoring is based on an interview with the caregiver and examination of the patient by an independent evaluator, without consulting other information such as cognitive test results. The CGIC range from 1 to 7, where 1=very much improved since the initiation of treatment; 4=no change from baseline; 7=very much worse since the initiation of treatment.

Outcome measures

Outcome measures
Measure	IVIG n=16 Participants ivig Intravenous Immunoglobulin	Placebo n=8 Participants
CGIC	NA units on a scale After extensive review of the records the actual calculations of the data cannot be located.	NA units on a scale After extensive review of the records the actual calculations of the data cannot be located.

Adverse Events

IVIG

Serious events: 0 serious events

Other events: 0 other events

Deaths: 10 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Norman Relkin, MD, PhD

Weill Cornell Medical College

Phone: 212-746-9882

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place