Trial Outcomes & Findings for Development of NIC5-15 in the Treatment of Alzheimer's Disease (NCT NCT00470418)

NCT ID: NCT00470418

Last Updated: 2017-01-09

Results Overview

vital signs, physical exam, Symptom Checklist, complete blood count, serum chemistries, urinalysis, and electrocardiogram

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: Safety Labs, Physical Exams: 6 times over 7 weeks. Adverse Events assessed 21 times over the course of 7 weeks
• Results posted on: 2017-01-09

Participant Flow

5 subjects did not meet entry criteria and were not baselined

Participant milestones

Measure	NIC5-15 NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects. Subjects received escalating doses of 1500, 3000 and 5000 mg daily over the course of the study. Subjects with Alzheimer's Disease	Placebo Placebo: placebo comparator identical in pill size, appearance and number Subjects with Alzheimer's Disease
Overall Study STARTED	7	3
Overall Study COMPLETED	6	3
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	NIC5-15 NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects. Subjects received escalating doses of 1500, 3000 and 5000 mg daily over the course of the study. Subjects with Alzheimer's Disease	Placebo Placebo: placebo comparator identical in pill size, appearance and number Subjects with Alzheimer's Disease
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Development of NIC5-15 in the Treatment of Alzheimer's Disease

Baseline characteristics by cohort

Measure	NIC5-15 n=7 Participants Subjects with Alzheimer's Disease NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects	Placebo n=3 Participants Subjects with Alzheimer's Disease Placebo: placebo comparator	Total n=10 Participants Total of all reporting groups
Age, Continuous	70.4 years STANDARD_DEVIATION 12.5 • n=5 Participants	69.7 years STANDARD_DEVIATION 13.9 • n=7 Participants	70.05 years STANDARD_DEVIATION .49 • n=5 Participants
Gender Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Gender Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Education	12.3 Years of Education STANDARD_DEVIATION 4.6 • n=5 Participants	18.0 Years of Education STANDARD_DEVIATION 2.0 • n=7 Participants	15.15 Years of Education STANDARD_DEVIATION 4.0 • n=5 Participants

PRIMARY outcome

Timeframe: Safety Labs, Physical Exams: 6 times over 7 weeks. Adverse Events assessed 21 times over the course of 7 weeks

vital signs, physical exam, Symptom Checklist, complete blood count, serum chemistries, urinalysis, and electrocardiogram

Outcome measures

Measure	NIC5-15 n=7 Participants Subjects with Alzheimer's Disease NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects	Placebo n=3 Participants Subjects with Alzheimer's Disease Placebo: placebo comparator
Safety Assessments: Number of Participants With Adverse Events	07 Participants	02 Participants

SECONDARY outcome

Timeframe: baseline and six weeks

Mini-Mental Status Exam (MMSE) 0(worst)-30(best); ADAS-cog 0 (best cognitive performance across multiple domains) - 70(worst); Activities of Daily Living (ADCS-ADL) 0(least capable of function in daily and instrumental activities)-54(best)

Outcome measures

Measure	NIC5-15 n=7 Participants Subjects with Alzheimer's Disease NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects	Placebo n=3 Participants Subjects with Alzheimer's Disease Placebo: placebo comparator
Changes From Baseline in Clinical Measures of Cognition at Terminal Visit MMSE	.8 units on a scale Standard Deviation 1.02	-5.3 units on a scale Standard Deviation 6.4
Changes From Baseline in Clinical Measures of Cognition at Terminal Visit ADAS-cog	2 units on a scale Standard Deviation 2.1	5.3 units on a scale Standard Deviation 3.2
Changes From Baseline in Clinical Measures of Cognition at Terminal Visit ADCS-ADLs	1 units on a scale Standard Deviation 2.8	1.7 units on a scale Standard Deviation 7.4

Adverse Events

NIC5-15

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	NIC5-15 n=7 participants at risk Subjects with Alzheimer's Disease NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects	Placebo n=3 participants at risk Subjects with Alzheimer's Disease Placebo: placebo comparator
Gastrointestinal disorders Diarrhea	14.3% 1/7 • Number of events 1	0.00% 0/3
Nervous system disorders Dizziness	0.00% 0/7	33.3% 1/3 • Number of events 1
Social circumstances Fall	14.3% 1/7 • Number of events 1	33.3% 1/3 • Number of events 1
Psychiatric disorders Insomnia	14.3% 1/7 • Number of events 1	0.00% 0/3
Musculoskeletal and connective tissue disorders Joint Pain	14.3% 1/7 • Number of events 1	0.00% 0/3
Gastrointestinal disorders Vomitting	14.3% 1/7 • Number of events 1	0.00% 0/3
Respiratory, thoracic and mediastinal disorders Scratchy Throat	14.3% 1/7 • Number of events 1	0.00% 0/3
Blood and lymphatic system disorders Hyperglycemic Lab Value	28.6% 2/7 • Number of events 2	0.00% 0/3
Skin and subcutaneous tissue disorders Discomfort and Pain at Needle Injection Site	14.3% 1/7 • Number of events 1	0.00% 0/3
Nervous system disorders Syncope	14.3% 1/7 • Number of events 1	0.00% 0/3
Blood and lymphatic system disorders Hypoglycemic Lab Value	14.3% 1/7 • Number of events 1	0.00% 0/3
Blood and lymphatic system disorders Low Hemocrit Lab Value	14.3% 1/7 • Number of events 1	0.00% 0/3
Skin and subcutaneous tissue disorders Bleeding from Scratch on Arm	14.3% 1/7 • Number of events 1	0.00% 0/3

Additional Information

Dr. Hillel Grossman

James J Peters VA Medical Center

Phone: 718-584-9000

Email: hillel.grossman2@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place