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A Pilot Clinical Trial of Exendin-4 in Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT01255163
Recruitment Status : Terminated (AstraZeneca withdrew support for the study.)
First Posted : December 7, 2010
Results First Posted : February 21, 2018
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Alzheimer's Disease
Mild Cognitive Impairment
Interventions Drug: Exendin-4 SC
Drug: Placebo SC
Enrollment 57
Recruitment Details Recruitment took place between 10/5/2010 and 7/25/2016. A total of 57 participants signed informed consent to undergo screening procedures. Of those, 28 qualified, 1 withdrew prior to randomization, 27 were randomized to exenatide or placebo, and 18 completed the study.
Pre-assignment Details The study includes a baseline visit to determine eligibility. Therefore, 57 participants were enrolled (i.e. signed informed consent prior to screening). Of those, 28 qualified, 1 withdrew prior to randomization, 27 were randomized to exenatide or placebo, and 18 completed the study.
Arm/Group Title Exendin-4 Placebo
Hide Arm/Group Description Exenatide 5 mcg or 10 mcg SC twice daily Placebo SC twice daily
Period Title: Overall Study
Started 13 14
Completed 9 9
Not Completed 4 5
Reason Not Completed
Withdrawal by Subject             1             0
Lost to Follow-up             2             0
Adverse Event             0             2
AstraZeneca stopped support of the study             1             3
Arm/Group Title Exendin-4 Placebo Total
Hide Arm/Group Description Exenatide 5 mcg or 10 mcg SC twice daily Placebo SC twice daily Total of all reporting groups
Overall Number of Baseline Participants 13 14 27
Hide Baseline Analysis Population Description
The baseline analysis population includes 27 participants who underwent randomization and received at least one dose of experimental medication. Of those 27, we have at least one outcome measure (i.e. at least the 6 months follow-up data point) for 21 participants. Of those 21, 18 completed the study (i.e. reached 18 months).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 14 participants 27 participants
70.46  (7.137) 74.64  (7.034) 72.63  (7.265)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
Female 6 9 15
Male 7 5 12
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
13
 100.0%
14
 100.0%
27
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   7.1%
1
   3.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   7.7%
1
   7.1%
2
   7.4%
White
12
  92.3%
12
  85.7%
24
  88.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 14 participants 27 participants
13 14 27
Cerebrospinal fluid amyloid-beta 42 (CSF Abeta42)   [1] 
Mean (Standard Deviation)
Unit of measure:  Pg/dl
Number Analyzed 13 participants 14 participants 27 participants
158.85  (43.619) 158.86  (33.558) 158.85  (37.963)
[1]
Measure Description: Measured in CSF using Luminex xMAP technology and INNO-BIA Alz Bio3 kits (Research Use Only) provided by Fujirebio
Mini Mental State Examination (MMSE)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 13 participants 14 participants 27 participants
25.85  (3.997) 24.64  (5.198) 25.22  (4.61)
[1]
Measure Description: Scale range: 0 - 30 points (higher is better)
Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog70)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 13 participants 14 participants 27 participants
14.46  (6.654) 13.64  (6.879) 14.04  (6.653)
[1]
Measure Description: Alzheimer's dementia scale cognitive sub-scale range: 0 - 70 points (higher is worse)
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 13 participants 14 participants 27 participants
26.631  (3.3673) 26.85  (5.2611) 26.744  (4.3687)
[1]
Measure Description: Body Mass Index defined as a person's weight in kilograms (kg) divided by his or her height in meters squared.
Fasting glucose  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 13 participants 14 participants 27 participants
94.92  (8.311) 90.14  (9.206) 92.44  (8.954)
Fasting insulin  
Mean (Standard Deviation)
Unit of measure:  uIU/ml
Number Analyzed 13 participants 14 participants 27 participants
8.53  (4.4337) 8.1  (4.5361) 8.254  (4.4628)
Cerebrospinal fluid phospho181-tau (CSF p181-tau)   [1] 
Mean (Standard Deviation)
Unit of measure:  Pg/dl
Number Analyzed 13 participants 14 participants 27 participants
56.62  (34.606) 40.64  (16.137) 48.33  (27.369)
[1]
Measure Description: Measured in CSF using Luminex xMAP technology and INNO-BIA Alz Bio3 kits (Research Use Only) provided by Fujirebio
Cerebrospinal fluid (CSF) Total Tau   [1] 
Mean (Standard Deviation)
Unit of measure:  Pg/dl
Number Analyzed 13 participants 14 participants 27 participants
90.38  (53.053) 70.64  (22.802) 80.15  (40.744)
[1]
Measure Description: Measured in CSF using Luminex xMAP technology and INNO-BIA Alz Bio3 kits (Research Use Only) provided by Fujirebio
Clinical Dementia Rating (CDR) global score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 13 participants 14 participants 27 participants
0.577  (0.2774) 0.607  (0.2129) 0.593  (0.2417)
[1]
Measure Description: Clinical Dementia Rating global score range: 0 (no dementia); 0.5 (Mild Cognitive Impairment); 1 (mild dementia); 2 (moderate dementia); 3 (severe dementia). Higher is worse.
Clinical Dementia Rating (CDR) sum of boxes   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 13 participants 14 participants 27 participants
2.769  (1.775) 3  (1.7759) 2.889  (1.745)
[1]
Measure Description: Sum of the Clinical Dementia Rating "boxes" (memory, orientation, judgment and problem solving, community affairs, home and hobbies, personal care). Each box is rated as 0, 0.5, 1, 2 or 3. Range for the sum of boxes is 0 - 18. Higher scores reflect a greater severity of dementia.
Nausea   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Nausea reported by participant
1.Primary Outcome
Title Number of Participants With Incidence of Nausea
Hide Description Tolerability of exenatide (nausea is the most common expected adverse event of exenatide)
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exendin-4 Placebo
Hide Arm/Group Description:
Exenatide 5 mcg or 10 mcg SC twice daily
Placebo SC twice daily
Overall Number of Participants Analyzed 13 14
Measure Type: Count of Participants
Unit of Measure: Participants
5
  38.5%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exendin-4, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments threshold for significance (p < 0.05)
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Mini Mental State Examination (MMSE)
Hide Description Scale range: 0 - 30 points (higher is better)
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exendin-4 Placebo
Hide Arm/Group Description:
Exenatide 5 mcg or 10 mcg SC twice daily
Placebo SC twice daily
Overall Number of Participants Analyzed 13 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
23.11  (6.009) 23.11  (5.011)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exendin-4, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.098
Comments

Threshold for statistical significance p < 0.05.

Type III Tests of Fixed Effects Group * VisitLong F (6, 52.008) = 1.902, p = 0.098

Method Mixed Models Analysis
Comments Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)
3.Secondary Outcome
Title Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog70)
Hide Description Alzheimer's dementia scale cognitive sub-scale range: 0 - 70 points (higher is worse)
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exendin-4 Placebo
Hide Arm/Group Description:

Exenatide 5 mcg or 10 mcg SC twice daily

Exendin-4 SC: Exenatide 5 mcg or 10 mcg SC twice daily

Placebo SC twice daily

Placebo SC: Placebo SC twice daily

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
16  (8.588) 17.78  (8.643)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exendin-4, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.295
Comments

Threshold for statistical significance p < 0.05.

Type III Tests of Fixed Effects for Group*VisitLong F (6, 52.281) = 1.254, p = 0.295

Method Mixed Models Analysis
Comments Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)
4.Secondary Outcome
Title Clinical Dementia Rating (CDR) Global Score
Hide Description Clinical Dementia Rating global score range: 0 (no dementia); 0.5 (Mild Cognitive Impairment); 1 (mild dementia); 2 (moderate dementia); 3 (severe dementia). Higher is worse.
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exendin-4 Placebo
Hide Arm/Group Description:
Exenatide 5 mcg or 10 mcg SC twice daily
Placebo SC twice daily
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.889  (0.6509) 0.833  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exendin-4, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.141
Comments Threshold for statistical significance p < 0.05. Type III Tests of Fixed Effects Group * VisitLong F (6, 47.485) = 1.704, p = 0.141
Method Mixed Models Analysis
Comments Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)
5.Secondary Outcome
Title Clinical Dementia Rating (CDR) Sum of Boxes
Hide Description Sum of the Clinical Dementia Rating "boxes" (memory, orientation, judgment and problem solving, community affairs, home and hobbies, personal care). Each box is rated as 0, 0.5, 1, 2 or 3. Range for the sum of boxes is 0 - 18. Higher scores reflect a greater severity of dementia.
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exendin-4 Placebo
Hide Arm/Group Description:
Exenatide 5 mcg or 10 mcg SC twice daily
Placebo SC twice daily
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.778  (4.0782) 4.5  (2.3318)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exendin-4, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments Threshold for statistical significance p < 0.05. Type III Tests of Fixed Effects: Group * VisitLong F (6, 51.955) = 2.553, p = 0.031. Univarate Exendin-4 F(3, 51.386) = 2.734, p = 0.053. Pairwise for Exendin-4, baseline vs. 18 months (p = 0.035).
Method Mixed Models Analysis
Comments Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)
6.Secondary Outcome
Title Cerebrospinal Fluid (CSF) Total Tau
Hide Description Total Tau measured in CSF using Luminex xMAP technology and INNO-BIA Alz Bio3 kits (Research Use Only) provided by Fujirebio
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exendin-4 Placebo
Hide Arm/Group Description:
Exenatide 5 mcg or 10 mcg SC twice daily
Placebo SC twice daily
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: pg/dl
86.57  (37.434) 70.75  (33.148)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exendin-4, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.703
Comments Threshold for statistical significance p < 0.05. Type III Tests of Fixed Effects Group * VisitLong F (2, 15.251) = 0.360, p = 0.703.
Method Mixed Models Analysis
Comments Repeated measures mixed model with Repeated Factor (Visit Long: baseline,18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)
7.Secondary Outcome
Title Cerebrospinal Fluid phospho181-tau (CSF p181-tau)
Hide Description p-181-Tau measured in CSF using Luminex xMAP technology and INNO-BIA Alz Bio3 kits (Research Use Only) provided by Fujirebio
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exendin-4 Placebo
Hide Arm/Group Description:
Exenatide 5 mcg or 10 mcg SC twice daily
Placebo SC twice daily
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: pg/dl
54.57  (32.893) 44.25  (19.739)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exendin-4, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.845
Comments Threshold for statistical significance p < 0.05. Type III Tests of Fixed Effects Group * VisitLong F (2, 15.828) = 0.170, p = 0.845.
Method Mixed Models Analysis
Comments Repeated measures mixed model with Repeated Factor (Visit Long: baseline,18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)
8.Secondary Outcome
Title Cerebrospinal Fluid Amyloid-beta 42 (CSF Abeta42)
Hide Description Abeta42 peptide measured in CSF using Luminex xMAP technology and INNO-BIA Alz Bio3 kits (Research Use Only) provided by Fujirebio
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exendin-4 Placebo
Hide Arm/Group Description:
Exenatide 5 mcg or 10 mcg SC twice daily
Placebo SC twice daily
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: pg/dl
177.43  (70.720) 176.38  (30.528)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exendin-4, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments Type III Tests of Fixed Effects: Group * VisitLong F (2, 16.614) = 5.142, p = 0.018. Univariate tests: Placebo F(1, 16.595) = 4.138, p = 0.058; Exendin-4 F(1, 16.595) = 6.262, p = 0.022. Pairwise for Exendin-4, baseline vs. 18 months (p = 0.022).
Method Mixed Models Analysis
Comments Repeated measures mixed model with Repeated Factor (Visit Long: baseline,18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)
9.Secondary Outcome
Title Body Mass Index (BMI)
Hide Description Body Mass Index defined as a person's weight in kilograms (kg) divided by his or her height in meters squared.
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exendin-4 Placebo
Hide Arm/Group Description:
Exenatide 5 mcg or 10 mcg SC twice daily
Placebo SC twice daily
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: kg/m^2
25.867  (3.6284) 25.789  (4.6023)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exendin-4, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments Type III Tests of Fixed Effects: Group * VisitLong F (8, 72.603) = 2.816, p = 0.009. Univarate Exendin-4 F(4, 72.944) = 4.834, p = 0.002. Pairwise comparisons for Exendin-4 showed a decrease in BMI baseline vs. 6 months (p = 0.029).
Method Mixed Models Analysis
Comments Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)
Time Frame Up to 18 months
Adverse Event Reporting Description Description of AEs according to clinicaltrials.gov definitions
 
Arm/Group Title Exendin-4 Placebo
Hide Arm/Group Description Exenatide 5 mcg or 10 mcg SC twice daily Placebo SC twice daily
All-Cause Mortality
Exendin-4 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)      0/14 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Exendin-4 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/13 (7.69%)      1/14 (7.14%)    
Cardiac disorders     
Myocardiac Infarction * [1]  1/13 (7.69%)  1 0/14 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Lung cancer * [2]  0/13 (0.00%)  0 1/14 (7.14%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Myocardiac Infarction treated with cardiac stent placement
[2]
Lung cancer diagnosed after pathological fracture 2 days after starting experimental drug
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Exendin-4 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/13 (100.00%)      9/14 (64.29%)    
Cardiac disorders     
Dyspnea on exertion * [1]  0/13 (0.00%)  1/14 (7.14%) 
Ear and labyrinth disorders     
Tinnitus *  1/13 (7.69%)  0/14 (0.00%) 
Endocrine disorders     
Thyroid abnormalities * [2]  1/13 (7.69%)  2/14 (14.29%) 
Eye disorders     
Allergic conjuctivitis *  1/13 (7.69%)  0/14 (0.00%) 
Floaters *  0/13 (0.00%)  1/14 (7.14%) 
Gastrointestinal disorders     
Nausea *  5/13 (38.46%)  0/14 (0.00%) 
Gastroesophageal reflux disease * [3]  2/13 (15.38%)  1/14 (7.14%) 
Lower abdominal pain * [4]  1/13 (7.69%)  0/14 (0.00%) 
Pancreatic enzyme elevation * [5]  2/13 (15.38%)  2/14 (14.29%) 
Diarrhea * [6]  3/13 (23.08%)  1/14 (7.14%) 
General disorders     
Fatigue *  2/13 (15.38%)  0/14 (0.00%) 
Infections and infestations     
Influenza *  1/13 (7.69%)  0/14 (0.00%) 
Injury, poisoning and procedural complications     
Post lumbar puncture headache * [7]  3/13 (23.08%)  3/14 (21.43%) 
Vomiting * [8]  1/13 (7.69%)  0/14 (0.00%) 
Metabolism and nutrition disorders     
Loss of appetite/weight loss * [9]  4/13 (30.77%)  0/14 (0.00%) 
Hypoglycemia symptoms * [10]  3/13 (23.08%)  2/14 (14.29%) 
Musculoskeletal and connective tissue disorders     
Orthopedic injuries * [11]  2/13 (15.38%)  2/14 (14.29%) 
Gout *  1/13 (7.69%)  0/14 (0.00%) 
Nervous system disorders     
Vasovagal syncope * [12]  2/13 (15.38%)  0/14 (0.00%) 
Lacunar stroke * [13]  0/13 (0.00%)  1/14 (7.14%) 
Renal and urinary disorders     
Abnormal kidney function tests * [14]  2/13 (15.38%)  2/14 (14.29%) 
Skin and subcutaneous tissue disorders     
Injection site ecchymosis and pain *  1/13 (7.69%)  1/14 (7.14%) 
*
Indicates events were collected by non-systematic assessment
[1]
Worsening DOE in participant with pre-existing cardiomyopathy
[2]
Two participants had changes in thyroid function tests (TSH and/or T4 or FT4) requiring a change in thyroxine regimen. One of them (placebo-treated) had symptomatic hypothyroidism. One placebo participant had thyroid nodules biopsied (benign).
[3]
GERD
[4]
Mild lower abdominal pain (all causes)
[5]
Asymptomatic elevation (over the upper normal limit) in serum amylase (and/or pancreatic-specific amylase) and/or serum lipase
[6]
Mild intermittent diarrhea (all causes)
[7]
Post lumbar puncture headache (all types). LP takes place during screening and at the 18 month outcome visit. One participant required blood patch after common analgesics and hydration did not provide relief.
[8]
Vomiting from lying flat on the MRI table
[9]
Loss of appetite leading to weight loss > 5 lb
[10]
Mild episodic symptoms consistent with hypoglycemia and relieved by meal (episodic fatigue and/or dizziness and/or lightheadedness and/or diaphoresis and/or nervousness and/or tremulousness). No episodes of severe symptomatic hypoglycemia.
[11]
Fractures (all types), lower back pain, strain, etc.
[12]
One participant had syncope during the LP procedure (the participant had hiatal hernia and the pressure from bending over caused nausea and vasovagal syncope). Another participant had syncope during a boar ride and experiencing sea sickness.
[13]
Asymptomatic subacute lacunar stroke discovered during ER work-up.
[14]
Elevation in serum BUN and/or creatinine and/or GFR (over the upper normal limit)
The study was terminated after AstraZeneca withdrew support. Early termination lead to small number of subjects analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dimitrios Kapogiannis, Clinical Investigator
Organization: National Institute on Aging (NIA/NIH)
Phone: 410-350-3953
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier: NCT01255163     History of Changes
Other Study ID Numbers: 100423
10-AG-0423
First Submitted: December 4, 2010
First Posted: December 7, 2010
Results First Submitted: November 8, 2017
Results First Posted: February 21, 2018
Last Update Posted: February 21, 2018