Status:
COMPLETED
Neptune Krill Oil (NKO™) in Early Stage Alzheimer's Disease (MNEMOSYNE)
Lead Sponsor:
NeuroBioPharm Inc.
Collaborating Sponsors:
Neptune Technologies and Bioressources Inc.
Conditions:
Early Onset Alzheimer Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
Alzheimer's disease (AD) is an irreversible, progressive neurodegenerative disorder, characterized by gradual cognitive deterioration, changes in behavior and personality. These symptoms are related t...
Eligibility Criteria
Inclusion
- 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 and/or treatment for any other psychiatric condition the dose must have been stable for six months prior to randomization and should continue to be on the same stable dose for the entire treatment duration.
- Patient is not taking fish oil or Omega 3/6 supplement 2 weeks before screening 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.
- If on a cholinesterase inhibitor treatment the dose must have been stable for at least six months prior to randomization and should continue to be on the same stable dose for the entire treatment duration.
- If on any concomitant medication treatment the dose must have been stable for at least four months prior to randomization and should continue to be on the same stable dose for the entire treatment duration.
- Written informed consent is obtained from the patient or the legally accepted representative.
- Exclusion criteria:
- Women who are pregnant or with childbearing potential and not willing to take adequate birth control measures.
- 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 are 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 \< 60% 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 known allergy to fish, seafood or soy/soy-derived products.
- Patient diagnosed with coagulopathy or on anticoagulant therapy
- Patient subject to symptomatic hypoglycemia.
- Patient requires to be initiated on an anti-depressant medication and/or treatment for any other psychiatric condition prior to randomization.
- Patient requires to be initiated on a cholinesterase inhibitor treatment prior to randomization.
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT00867828
Start Date
May 1 2009
End Date
January 1 2011
Last Update
October 3 2011
Active Locations (14)
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1
Surrey, British Columbia, Canada
2
Deer Lake, Newfoundland and Labrador, Canada
3
St. John's, Newfoundland and Labrador, Canada
4
Cornwall, Ontario, Canada