Neptune Krill Oil (NKO™) in Early Stage Alzheimer's Disease (MNEMOSYNE) - Full Text View

Sponsors and Collaborators:	NeuroBioPharm Inc. Neptune Technologies and Bioressources Inc.
Information provided by:	NeuroBioPharm Inc.
ClinicalTrials.gov Identifier:	NCT00867828

Purpose

The purpose of this study is to evaluate the efficacy of NKO™ softgels in reducing decline of global cognitive function as measured by the Neuropsychological Test Battery (NTB), in patients diagnosed with early stage Alzheimer's disease when compared to fish oil and a placebo after 24 weeks of treatment.

Condition	Intervention	Phase
Early Onset Alzheimer Disease	Dietary Supplement: Neptune Krill Oil Dietary Supplement: Fish Oil Dietary Supplement: Placebo (soy oil)	Phase IV

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dietary Supplements Diets

Drug Information available for: Soybean oil Fish oil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multi-Center, Double-Blind, Placebo-Controlled, Monotherapy Study of Neptune Krill Oil (NKO™) in Early Stage Alzheimer's Disease

Further study details as provided by NeuroBioPharm Inc.:

Primary Outcome Measures:

The primary outcome measure will be the change in Neurological Test Battery between baseline and 24 weeks of treatment. [ Time Frame: Between baseline and 24 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary outcome measures will include the change in DAD at 24 weeks of treatment, the change in NTB, GDS, DAD, and MMSE at 12 weeks.Safety and tolerability will be assessed by the incidence of treatment emergent adverse events. [ Time Frame: 24 week period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	189
Study Start Date:	April 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Neptune Krill Oil(TM) (135 mg EPA: 108 mg DHA) softgels (1g QD)	Dietary Supplement: Neptune Krill Oil 135 mg EPA: 108 mg DHA softgels (1g QD)
2: Active Comparator Fish oil (135 mg EPA: 108 mg DHA) softgels (1g QD)	Dietary Supplement: Fish Oil 135 mg EPA: 108 mg DHA softgels (1g QD)
3: Placebo Comparator Placebo (soy oil) softgels (1g QD)	Dietary Supplement: Placebo (soy oil) 1g QD

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Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients aged 50 years or older.
Patients with a clinical diagnosis of early stage Alzheimer's disease (NINCDS-ADRDA criteria) and with a Standardized Mini-Mental State Examination (MMSE) score of 20 - 26 inclusively and have demonstrated decline in their cognitive functions during the last six months as determined by the treating physicians.
Patient has a score < 9 on the Hamilton Rating Scale for Depression (Ham-D) (Vida et al., 1994; Naarding et al., 2002).

If on anti-depressant treatment the dose must have been stable for six months prior to study initiation.

Patient is not taking fish oil or Omega 3/6 supplement 2 weeks before visit.
Patient is living at home or in a home for elderly persons.
Patient has a responsible caregiver who is able to provide information about the patient's functional status.
Patients that require treatment with a cholinesterase inhibitor during the study follow up period will be continued in the study and will be treated with the study drug in combination with the cholinesterase inhibitors.
Written informed consent is obtained from the patient or the legally accepted representative.

Exclusion Criteria:

Severe or unstable diseases of any type, other than cognitive impairment, that may interfere with outcome evaluations. These include medical conditions expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the patient to a significant degree or put the patient at special risk.
Intake of fish oil or Omega 3/6 supplement other than the study drug
Patients taking more than 400 mg vitamin E.
The patient is not able to reliably take the study medication for the duration of the study (Patient compliance is < 80% after the 2-week run-in period).
Patients with severe medical condition(s) that in the view of the treating physician prohibits participation in the study.
Patients using any other investigational agent, or participating in another study within the last 30 days prior to the baseline visit.
Patient with fish or seafood allergy
Patient diagnosed with coagulopathy or on anticoagulant therapy

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	NeuroBioPharm Inc. ( Tina Sampalis, M.D., Ph.D., President )
Study ID Numbers:	NBP-4209AD
Study First Received:	March 23, 2009
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00867828 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by NeuroBioPharm Inc.:

Decline of global cognitive function
Neuropsychological Test Battery (NTB)
Early stage Alzheimer's disease

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009