The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study

Alzheimer's Disease Clinical Trial

— PLASMA  

Official title:

The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study: Intravenously-Administered Plasma From Young Donors for Treatment of Mild-To-Moderate Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02256306
• Other study ID #: 30350
• Status: Completed
• Phase: N/A
• First received: September 25, 2014
• Last updated: October 9, 2017
• Start date: September 2014
• Est. completion date: February 2017

Study information

• Verified date: October 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study: Intravenously-Administered Plasma From Young Donors for Treatment of Mild-To-Moderate Alzheimer's Disease

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• Diagnosis of probable Alzheimer's disease (NIA-AA criteria)

• Mini-Mental State Examination (MMSE) score 12-24

• Availability of a study partner who knows the patient well and is willing to accompany the subject to all trial visits, to participate in questionnaires and to complete daily journal assessments

Exclusion Criteria:

• Pregnancy or unwilling to use adequate birth control method for duration of and 6 months beyond study participation

• Positive for Hepatitis B, Hepatitis C or HIV at screening

• Any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study

• Related to medical history:

• Stroke

• Anaphylaxis

• Prior adverse reaction to any human blood product

• Any history of a blood coagulation disorder or hypercoagulability

• Congestive heart failure

• Uncontrolled hypertension

• Renal failure

• Prior intolerance to intravenous fluids

• Recent history of uncontrolled atrial fibrillation

• IgA deficiency (by history)

• Related to medications or other treatments:

• Any concurrent use of an anticoagulant therapy. Antiplatelet drugs (e.g., aspirin or clopidogrel) are acceptable

• Initiation or change in the dosage of a cholinesterase inhibitor or memantine during the trial. A participant already on a cholinesterase inhibitor or memantine must be on a stable dose for at least one month prior to Screening

• Concurrent participation in another treatment trial for Alzheimer's disease. If there was prior participation, the last dose of the investigational agent must have been at least 6 months prior to Screening

• Treatment with any human blood product, including intravenous immunoglobulin, during the 6 months prior to Screening or during the trial

• Concurrent daily treatment with benzodiazepines, typical or atypical antipsychotics, long-acting opioids, or other medications that, in the investigator's opinion, interfere with cognition. Intermittent treatment with short-acting benzodiazepines or atypical antipsychotics may be permitted, provided that no dose is administered within the 72 hours preceding any cognitive assessment

• Related to magnetic resonance imaging:

• Claustrophobia

• Any metallic surgical implant, like a pacemaker or clip that is incompatible with 3T MRI.

Certain metallic implants like joint replacements may be permitted, provided that specific manufacturer specifications are available and that the device is known to be safe for 3T MRI.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Mild-To-Moderate Alzheimer's Disease

Intervention

Other:
• Plasma
1 unit of Plasma From Young Donors (Male, aged 30 or younger)

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Alkahest, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in functional connectivity in the default mode network as assessed by resting state functional MRI		9 weeks
Other	Compositional assessment of plasma using in vitro analytical methods. The goal is to assess plasma components that might be associated with aging and/or Alzheimer's disease		9 weeks
Other	In vivo assessment of plasma samples to determine their potential histological effects on the hippocampus and their potential behavioral effects in animal models of cognition		9 weeks
Other	Differential effect of therapy on above outcomes as a function of ApoE genotype		9 weeks
Primary	Number of participants with adverse events as a measure of safety and tolerability, and number of subjects who comply with the research protocol as a measure of feasibility.		9 weeks
Secondary	Change on the 13-item ADAS-Cog		9 weeks
Secondary	Change on the Trail-Making Test		9 weeks
Secondary	Change on the Clinical Dementia Rating scale Sum of Boxes (CDR-SB)		9 weeks
Secondary	Change on the Functional Activities Questionnaire (FAQ)		9 weeks
Secondary	Change on the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)		9 weeks
Secondary	Change on the Geriatric Depression Scale		9 weeks
Secondary	Change on the Neuropsychiatric Inventory Questionnaire (NPI-Q)		9 weeks